New tools of the trade.

Abstract:

:The author reviews the regulatory process through which new cardiovascular interventional devices reach the hands of the interventional radiologist and the cardiologist. The marketing mechanisms are outlined, as are the data requirements. The reader is taken step-by-step from device investigation conducted under an approved investigational device exemptions application to market clearance, through either a substantially equivalent 510(k) notification or an approved premarket approval application, and beyond, including how to report adverse device experiences through the Medical Device Reporting REgulation and the Medical Device and Laboratory Product Problem Reporting Program.

journal_name

Radiology

journal_title

Radiology

authors

Reamer LA

doi

10.1148/radiology.174.3.174-3-923

subject

Has Abstract

pub_date

1990-03-01 00:00:00

pages

923-5

issue

3 Pt 2

eissn

0033-8419

issn

1527-1315

journal_volume

174

pub_type

临床试验,杂志文章
  • Mn-DPDP in MR imaging of pancreatic adenocarcinoma: initial clinical experience.

    abstract::Manganese (II) N,N'-dipyridoxylethylenediamine-N,N'-diacetate 5,5'-bis(phosphate) (DPDP) was tested as a contrast agent for magnetic resonance imaging of pancreatic adenocarcinoma in 15 patients. At enhanced T1-weighted spin-echo (SE) and enhanced T1-weighted gradient-echo (GRE) imaging, statistically significant incr...

    journal_title:Radiology

    pub_type: 临床试验,杂志文章

    doi:10.1148/radiology.186.3.8430190

    authors: Gehl HB,Urhahn R,Bohndorf K,Klever P,Hauptmann S,Lodemann KP,Matern S,Schumpelick V,Günther RW

    更新日期:1993-03-01 00:00:00

  • Hyperintense dentate nucleus on unenhanced T1-weighted MR images is associated with a history of brain irradiation.

    abstract:PURPOSE:To assess the frequency of hyperintensity in the dentate nucleus on T1-weighted magnetic resonance (MR) images and to establish correlations between such hyperintensity and clinical factors, including a history of brain irradiation. MATERIALS AND METHODS:This study was approved by the institutional review boar...

    journal_title:Radiology

    pub_type: 杂志文章

    doi:10.1148/radiol.10100508

    authors: Kasahara S,Miki Y,Kanagaki M,Yamamoto A,Mori N,Sawada T,Taoka T,Okada T,Togashi K

    更新日期:2011-01-01 00:00:00

  • Colorectal hepatic metastases: detection with SPIO-enhanced breath-hold MR imaging--comparison of optimized sequences.

    abstract:PURPOSE:To compare the accuracy of four breath-hold magnetic resonance (MR) imaging sequences to establish the most effective superparamagnetic iron oxide (SPIO)-enhanced sequence for detection of colorectal hepatic metastases. MATERIALS AND METHODS:Thirty-one patients with colorectal hepatic metastases underwent T1-w...

    journal_title:Radiology

    pub_type: 杂志文章

    doi:10.1148/radiol.2283020376

    authors: Ward J,Guthrie JA,Wilson D,Arnold P,Lodge JP,Toogood GJ,Wyatt JI,Robinson PJ

    更新日期:2003-09-01 00:00:00

  • Virtual dissection CT colonography: evaluation of learning curves and reading times with and without computer-aided detection.

    abstract:PURPOSE:To prospectively evaluate the learning curves and reading times of inexperienced readers who used the virtual dissection reading method for retrospective computed tomographic (CT) colonography data sets, with and without concurrent computer-aided detection (CAD). MATERIALS AND METHODS:An Institutional Review B...

    journal_title:Radiology

    pub_type: 杂志文章

    doi:10.1148/radiol.2482070895

    authors: Hock D,Ouhadi R,Materne R,Aouchria AS,Mancini I,Broussaud T,Magotteaux P,Nchimi A

    更新日期:2008-09-01 00:00:00

  • Arthropathy in Behçet disease: MR imaging findings in two cases.

    abstract::Arthropathy is part of the protean manifestations of Behçet disease. Imaging findings reported thus far have been based on those of conventional radiography. Magnetic resonance imaging in two cases of Behçet disease with arthropathy demonstrated synovial thickening and effusion, as well as myositis manifested by high ...

    journal_title:Radiology

    pub_type: 杂志文章

    doi:10.1148/radiol.2262011982

    authors: Choi JA,Kim JE,Koh SH,Chung HW,Kang HS

    更新日期:2003-02-01 00:00:00

  • Subcortical damage and cortical functional changes in men and women with Fabry disease: a multifaceted MR study.

    abstract:PURPOSE:To prospectively compare brain magnetic resonance (MR) imaging and hydrogen 1 (1H) MR spectroscopy findings and to use functional MR imaging to explore the patterns of brain activation in men and women with Fabry disease (FD). MATERIALS AND METHODS:Eight men and eight women with FD (mean age, 38.8 years +/- 13...

    journal_title:Radiology

    pub_type: 杂志文章

    doi:10.1148/radiol.2412051122

    authors: Gavazzi C,Borsini W,Guerrini L,Della Nave R,Rocca MA,Tessa C,Buchner S,Belli G,Filippi M,Villari N,Mascalchi M

    更新日期:2006-11-01 00:00:00

  • Osteoarthritis of the facet joints: accuracy of oblique radiographic assessment.

    abstract::Sensitivity and specificity of lumbar spine radiography in the assessment of facet joint osteoarthritis were evaluated, with computed tomography (CT) as the standard. Two independent radiologists used a four-point scale to blindly grade facet joint osteoarthritis on oblique radiographs and transaxial CT scans obtained...

    journal_title:Radiology

    pub_type: 杂志文章

    doi:10.1148/radiology.164.1.3588910

    authors: Pathria M,Sartoris DJ,Resnick D

    更新日期:1987-07-01 00:00:00

  • Diagnosis of biliary atresia with radionuclide hepatobiliary imaging.

    abstract::Sixteen patients with biliary atresia and 11 patients with neonatal hepatitis were studied preoperatively with either Tc-99m-diethyl-IDA or TC-99m-diisopropyl-IDA. Two parameters were evaluated: hepatocyte clearance and time to appearance of radioactivity in the intestine. Two observers, using a visual grading system ...

    journal_title:Radiology

    pub_type: 杂志文章

    doi:10.1148/radiology.146.2.6681570

    authors: Gerhold JP,Klingensmith WC 3rd,Kuni CC,Lilly JR,Silverman A,Fritzberg AR,Nixt TL

    更新日期:1983-02-01 00:00:00

  • Biopsy of the right adrenal gland by the transhepatic approach.

    abstract::A transhepatic computed-tomographic-guided biopsy of a right adrenal mass is described. This method is simpler to perform than the usual posterior biopsy carried out with the patient prone and is less likely to cause a complicating pneumothorax. In seven of eight patients with right adrenal masses, adrenal tissue was ...

    journal_title:Radiology

    pub_type: 杂志文章

    doi:10.1148/radiology.148.2.6867360

    authors: Price RB,Bernardino ME,Berkman WA,Sones PJ Jr,Torres WE

    更新日期:1983-08-01 00:00:00

  • Kidney Injury after Intravenous versus Intra-arterial Contrast Agent in Patients Suspected of Having Coronary Artery Disease: A Randomized Trial.

    abstract::Background In the absence of randomized studies, it has been controversial whether the likelihood of acute kidney injury (AKI) differs between intravenous and intra-arterial contrast agent administration. Purpose To compare intravenous versus intra-arterial contrast agent administration in relationship to AKI and anal...

    journal_title:Radiology

    pub_type: 杂志文章,随机对照试验

    doi:10.1148/radiol.2019182220

    authors: Schönenberger E,Martus P,Bosserdt M,Zimmermann E,Tauber R,Laule M,Dewey M

    更新日期:2019-09-01 00:00:00

  • Imaging of the percutaneous cholecystostomy tract: observations and utility.

    abstract::The technique and observations in 28 patients who underwent imaging of the percutaneous cholecystostomy (PC) tract are described. Imaging of the tracts was performed by injecting contrast material through an end-hole dilator during catheter removal (n = 13) or through an end-hole dilator with a side adapter over a thi...

    journal_title:Radiology

    pub_type: 杂志文章

    doi:10.1148/radiology.181.3.1947080

    authors: D'Agostino HB,vanSonnenberg E,Sanchez RB,Goodacre BW,Casola G

    更新日期:1991-12-01 00:00:00

  • The year 2000 threat: preparing radiology for nine realms of risk.

    abstract::The year 2000 computer problem arises from a long-standing and often-duplicated computer programming error. Affected programs use only two digits to represent years, which may lead to a variety of computer malfunctions and data errors related to crossing from 1999 (99) to 2000 (00), at which point computers may interp...

    journal_title:Radiology

    pub_type: 杂志文章

    doi:10.1148/radiology.210.1.r99ja4417

    authors: Berland LL

    更新日期:1999-01-01 00:00:00

  • Dynamic contrast-enhanced subtraction MR angiography of the lower extremities: initial evaluation with a multisection two-dimensional time-of-flight sequence.

    abstract:PURPOSE:To determine the clinical feasibility of a contrast material--enhanced two-dimensional (2D) magnetic resonance (MR) angiographic sequence in lower extremity arteries. MATERIALS AND METHODS:Four healthy volunteers and 12 patients underwent dynamic contrast-enhanced MR angiography; all patients also underwent co...

    journal_title:Radiology

    pub_type: 杂志文章

    doi:10.1148/radiology.196.3.7644630

    authors: Adamis MK,Li W,Wielopolski PA,Kim D,Sax EJ,Kent KC,Edelman RR

    更新日期:1995-09-01 00:00:00

  • Inflammatory fibroid polyp of the colon simulating malignancy.

    abstract::The authors report an inflammatory fibroid polyp of the colon which simulated a tumor on the air-contrast barium-enema examination. Histological evaluation revealed the inflammatory nature of the polyp. These rare lesions can be radiographically indistinguishable from primary colon carcinoma. ...

    journal_title:Radiology

    pub_type: 杂志文章

    doi:10.1148/radiology.149.1.6611950

    authors: Ferin P,Skucas J

    更新日期:1983-10-01 00:00:00

  • The influence of hypoxia and acidity on the hyperthermic response of malignant cells in vitro.

    abstract::Colony formation of JB-1-E tumor cells was studied after hyperthermic treatment (42.5 degrees C) at a pH of 6.4 or 7.2 under hypoxic and euoxic conditions. At a pH of 7.2 and normal oxygen tension, there was a moderate decrease in colony formation with increasing duration of hyperthermic treatment (To = 65 min.). This...

    journal_title:Radiology

    pub_type: 杂志文章

    doi:10.1148/123.2.511

    authors: Overgaard J,Bichel P

    更新日期:1977-05-01 00:00:00

  • The changing role of external-beam irradiation in the management of malignant tumors of the major salivary glands.

    abstract::Postoperative irradiation reduces the local recurrence rate for malignant salivary gland tumors. Less extensive surgery followed by immediate radiotherapy is possible without decreasing local control; moreover, cosmetic appearance and physiological function are preserved. Local tumor control was achieved in 16 out of ...

    journal_title:Radiology

    pub_type: 杂志文章

    doi:10.1148/radiology.145.1.6812160

    authors: Chung CT,Sagerman RH,Ryoo MC,King GA,Yu WS,Dalal PS

    更新日期:1982-10-01 00:00:00

  • Human carcinoma: early experience with phase-contrast X-ray CT with synchrotron radiation--comparative specimen study with optical microscopy.

    abstract::Phase-contrast x-ray computed tomography (CT) indicates the distribution of the refractive index and has potential to reveal the structures inside soft tissues without a contrast agent. With a synchrotron x-ray source, phase-contrast x-ray CT with a triple Laue-case x-ray interferometer clearly differentiated various ...

    journal_title:Radiology

    pub_type: 杂志文章

    doi:10.1148/radiology.214.1.r00ja08298

    authors: Takeda T,Momose A,Hirano K,Haraoka S,Watanabe T,Itai Y

    更新日期:2000-01-01 00:00:00

  • Laser therapy for breast cancer: MR imaging and histopathologic correlation.

    abstract:PURPOSE:To investigate magnetic resonance (MR) imaging guidance of interstitial laser photocoagulation to treat primary breast cancer. MATERIALS AND METHODS:Twenty female patients with symptomatic breast cancers diagnosed at cytologic examination underwent interstitial laser photocoagulation by means of a single fiber...

    journal_title:Radiology

    pub_type: 杂志文章

    doi:10.1148/radiology.200.3.8756910

    authors: Mumtaz H,Hall-Craggs MA,Wotherspoon A,Paley M,Buonaccorsi G,Amin Z,Wilkinson I,Kissin MW,Davidson TI,Taylor I,Bown SG

    更新日期:1996-09-01 00:00:00

  • Kidneys in infants and children: evaluation with MR.

    abstract::Magnetic resonance (MR) imaging was performed in 58 children aged 1 day to 17 years. In 43 patients with suspected renal abnormalities, the results of MR were compared with those obtained by ultrasonography, computed tomography, or excretory urography. The remaining 15 children with no known renal disease were initial...

    journal_title:Radiology

    pub_type: 杂志文章

    doi:10.1148/radiology.159.1.3952310

    authors: Dietrich RB,Kangarloo H

    更新日期:1986-04-01 00:00:00

  • Atypical ductal hyperplasia diagnosed at stereotactic breast biopsy: improved reliability with 14-gauge, directional, vacuum-assisted biopsy.

    abstract:PURPOSE:To compare histologic findings of atypical ductal hyperplasia (ADH) at 14-gauge, directional, vacuum-assisted breast biopsy (hereafter, vacuum-assisted biopsy) and at 14-gauge, automated, large-core breast biopsy (hereafter, large-core biopsy) with findings at histologic examination after surgical biopsy. MATE...

    journal_title:Radiology

    pub_type: 杂志文章,多中心研究

    doi:10.1148/radiology.204.2.9240540

    authors: Jackman RJ,Burbank F,Parker SH,Evans WP 3rd,Lechner MC,Richardson TR,Tocino I,Wray AB

    更新日期:1997-08-01 00:00:00

  • Cataract Risk in a Cohort of U.S. Radiologic Technologists Performing Nuclear Medicine Procedures.

    abstract::Purpose To estimate the risk of cataract in a cohort of nuclear medicine (NM) radiologic technologists on the basis of their work histories and radiation protection practices. Materials and Methods In the years 2003-2005 and 2012-2013, 42 545 radiologic technologists from a U.S. prospective study completed questionnai...

    journal_title:Radiology

    pub_type: 杂志文章

    doi:10.1148/radiol.2017170683

    authors: Bernier MO,Journy N,Villoing D,Doody MM,Alexander BH,Linet MS,Kitahara CM

    更新日期:2018-02-01 00:00:00

  • Mapping T2 relaxation time in the pediatric knee: feasibility with a clinical 1.5-T MR imaging system.

    abstract:PURPOSE:To determine the feasibility of mapping the spatial variation of cartilage T2 relaxation time in vivo in the pediatric knee with a 1.5-T clinical magnetic resonance (MR) imaging system and the manufacturer's body gradient coil. MATERIALS AND METHODS:Twenty-five children and adolescents (age range, 5-17 years; ...

    journal_title:Radiology

    pub_type: 杂志文章

    doi:10.1148/radiol.2251011461

    authors: Dardzinski BJ,Laor T,Schmithorst VJ,Klosterman L,Graham TB

    更新日期:2002-10-01 00:00:00

  • Lymphatico-osseous communication and primary lymphedema.

    abstract::A lymphatico-osseous communication was demonstrated by lymphangiography in a patient with primary lymphedema of the left leg. The superficial lymph vessels were markedly hyperplastic and contrast medium was visible within the epiphyseal portions of the femur, tibia, fibula, and foot bones. Biopsy of the affected femur...

    journal_title:Radiology

    pub_type: 杂志文章

    doi:10.1148/129.2.375

    authors: Abe R

    更新日期:1978-11-01 00:00:00

  • Use of CT in stapedial otosclerosis.

    abstract::Otosclerosis (otospongiosis) is a primary focal disease of the labyrinthine capsule. The stapes footplate is fixed when the spongiotic focus expands and invades the oval window. Persons with stapedial otosclerosis experience a progressive conductive hearing loss. In many cases, cochlear degeneration is observed, in wh...

    journal_title:Radiology

    pub_type: 杂志文章

    doi:10.1148/radiology.156.3.4023230

    authors: Mafee MF,Henrikson GC,Deitch RL,Norouzi P,Kumar A,Kriz R,Valvassori GE

    更新日期:1985-09-01 00:00:00

  • Subtraction radiography: techniques and limitations.

    abstract::Subtraction radiography permits the use of 7-10 times less contrast material than is required without subtraction techniques. The first-order, second-order, and composite mask techniques are described and evaluated. While the second-order technique gives more complete cancellation of common structures, the more common...

    journal_title:Radiology

    pub_type: 杂志文章

    doi:10.1148/124.1.65

    authors: Ort MG,Gregg EC,Kaufman B

    更新日期:1977-07-01 00:00:00

  • Cranial bone marrow in children: assessment of normal development with MR imaging.

    abstract::Magnetic resonance images of cranial bone marrow in 238 patients (246 examinations) less than 25 years old were reviewed to establish normal age-related standards. Bone marrow in the clivus and calvaria had uniformly low signal intensity (grade 1) on T1-weighted images in most infants less than 1 year old. The number ...

    journal_title:Radiology

    pub_type: 杂志文章

    doi:10.1148/radiology.171.1.2928520

    authors: Okada Y,Aoki S,Barkovich AJ,Nishimura K,Norman D,Kjos BO,Brasch RC

    更新日期:1989-04-01 00:00:00

  • Intervertebral disk-space infection: CT changes. Work in progress.

    abstract::Seven patients who had spinal interspace infections underwent clinical, laboratory, and radiographic examinations, and findings are reported. Lytic fragmentation of adjacent vertebral bodies is a characteristic appearance on CT scans. Sagittal-coronal reformations confirm the end-plate irregularity and establish the d...

    journal_title:Radiology

    pub_type: 杂志文章

    doi:10.1148/radiology.149.3.6647850

    authors: Price AC,Allen JH,Eggers FM,Shaff MI,James AE Jr

    更新日期:1983-12-01 00:00:00

  • Papillary process of the caudate lobe of the liver: sonographic appearance.

    abstract::The papillary process of the caudate lobe of the liver may appear separate from the liver and thus mimic lymph nodes or a pancreatic mass. In order to evaluate the sonographic appearance of this anatomic structure, 400 male and female patients with a mean age of 50 years were studied prospectively by means of ultrasou...

    journal_title:Radiology

    pub_type: 杂志文章

    doi:10.1148/radiology.173.3.2682770

    authors: Donoso L,Martínez-Noguera A,Zidan A,Lora F

    更新日期:1989-12-01 00:00:00

  • Lung torsion: case report and literature review.

    abstract::A 65-year-old woman with endobronchial carcinoma had torsion of the left upper lobe. A posteroanterior chest radiograph showed apparent atelectasis in the left upper lobe, but the lateral view disclosed an inappropriate posterior displacement of the collapsed lobe. The vasculature of the affected area showed an unusua...

    journal_title:Radiology

    pub_type: 杂志文章,评审

    doi:10.1148/radiology.162.3.3544030

    authors: Moser ES Jr,Proto AV

    更新日期:1987-03-01 00:00:00

  • Dutch iliac stent trial: long-term results in patients randomized for primary or selective stent placement.

    abstract:PURPOSE:To determine long-term results of the prospective Dutch Iliac Stent Trial. MATERIALS AND METHODS:The study protocol was approved by local institutional review boards. All patients gave written informed consent. Two hundred seventy-nine patients (201 men, 78 women; mean age, 58 years) with iliac artery disease ...

    journal_title:Radiology

    pub_type: 杂志文章,随机对照试验

    doi:10.1148/radiol.2382041053

    authors: Klein WM,van der Graaf Y,Seegers J,Spithoven JH,Buskens E,van Baal JG,Buth J,Moll FL,Overtoom TT,van Sambeek MR,Mali WP

    更新日期:2006-02-01 00:00:00