FDA Review Panel · RA

FDA 510(k) Radiology Devices

FDA 510(k) Radiology Devices - Regulatory Overview

FDA 510(k) radiology devices include medical imaging systems and radiation therapy equipment. The FDA review panel code is RA.

Key modalities covered:

  • X-ray and fluoroscopy - digital radiography, fluoroscopy systems and C-arms
  • Computed tomography (CT) - whole-body and dedicated CT scanners
  • Magnetic resonance imaging (MRI) - 1.5T, 3T and extremity MRI systems
  • Ultrasound imaging - diagnostic, point-of-care and intravascular ultrasound
  • Radiation therapy - linear accelerators, brachytherapy and treatment planning
  • Nuclear medicine - PET, SPECT and gamma camera systems

15620
Total
15601
Cleared
148d
Avg (2y)
1976
Since
12612 Radiology devices
6051–6075 of 12612
Cleared Sep 01, 2011
VOLUSON E6, E8, E8 EXPERT, E10 DIAGNOSTIC ULTRASOUND SYSTEM
K112213 · Ge Healthcare
IYN · System, Imaging, Pulsed Doppler, Ultrasonic · 30d
Cleared Sep 01, 2011
ASPIRE HD FULL-FIELD DIGITAL MAMMOGRAPHY SYSTEM
K110729 · Fujifilm Medical Systems U.S.A, Inc.
MUE · Full Field Digital, System, X-ray, Mammographic · 169d
Cleared Aug 30, 2011
WIRELESS/WIRED FDR D-EVO FLAT PANCEL DETECTOR SYSTEM MODEL DR-ID600 W/DR-ID611SE
K111548 · Fujifilm Medical System U.S.A., Inc.
MQB · Solid State X-ray Imager (flat Panel/digital Imager) · 88d
Cleared Aug 29, 2011
ACCUVIX A30 DIAGNOSTIC ULTRASOUND SYSTEM
K112339 · Samsung Medison Co., Ltd.
IYN · System, Imaging, Pulsed Doppler, Ultrasonic · 14d
Cleared Aug 29, 2011
AIDA HD CONNECT WITH SMARTSCREEN / BLU-RAY DRIVE / SMARTSCREEN WITH BLU-RAY DRIVE
K103308 · KARL STORZ Endoscopy-America, Inc.
LLZ · System, Image Processing, Radiological · 293d
Cleared Aug 26, 2011
ZENIS, PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM
K103181 · Genoray Co., Ltd.
LLZ · System, Image Processing, Radiological · 302d
Cleared Aug 25, 2011
SENTINELLE BREAST MRI TABLETOP WITH 16 CHANNEL COIL ARRAY FOR SIEMENS 1.5/3T MRI SYSTEMS
K112112 · Sentinel Medical, Inc.
MOS · Coil, Magnetic Resonance, Specialty · 31d
Cleared Aug 25, 2011
AQUILION LB MOVEMENT BASE KIT
K111633 · Toshiba America Medical Systems, In.C
JAK · System, X-ray, Tomography, Computed · 73d
Cleared Aug 23, 2011
CT42 CARDIAC COMPUTED TOMOGRAPHY (CT) SOFTWARE
K111373 · Circle Cardiovascular Imaging, Inc.
LLZ · System, Image Processing, Radiological · 99d
Cleared Aug 23, 2011
DDRELEMENT
K110828 · Swissray Medical AG
KPR · System, X-ray, Stationary · 152d
Cleared Aug 19, 2011
TRIDENT SPECIMEN RADIOGRAPHY SYSTEM, MODEL : RC TRI-00001
K111508 · Hologic, Inc.
MWP · Cabinet, X-ray System · 79d
Cleared Aug 18, 2011
SYNGO.CT VASCULAR ANALYSIS
K112020 · Siemens Medi Cal Solutions, Inc.
JAK · System, X-ray, Tomography, Computed · 35d
Cleared Aug 18, 2011
XTENDER FILM PROCESSOR, SPRINT FILM PROCESSOR MODEL XTENDER MODEL SPRINT
K111167 · Velopex International, Inc.
IXW · Processor, Radiographic-film, Automatic · 114d
Cleared Aug 18, 2011
TRUEBEAM
K111106 · Varian Medical Systems, Inc.
IYE · Accelerator, Linear, Medical · 120d
Cleared Aug 18, 2011
CS 9300, CS 9300C
K103659 · Trophy
OAS · X-ray, Tomography, Computed, Dental · 246d
Cleared Aug 18, 2011
SENTINELLE ENDO COIL ARRAY FOR PELVIC IMAGING
K103274 · Sentinelle Medical, Inc.
MOS · Coil, Magnetic Resonance, Specialty · 286d
Cleared Aug 12, 2011
ISROBOT MONA LISA
K111347 · Biobot Surgical Pte., Ltd.
IYO · System, Imaging, Pulsed Echo, Ultrasonic · 91d
Cleared Aug 12, 2011
BRIVO XR385
K103448 · Ge Medical Systems, LLC
KPR · System, X-ray, Stationary · 261d
Cleared Aug 11, 2011
NIO COLOR 2MP
K111991 · Barco N.V.
LLZ · System, Image Processing, Radiological · 29d
Cleared Aug 10, 2011
I5 DIGITAL X-RAY IMAGING SYSTEM (WITH SDX-4336CP)
K112180 · Infimed, Inc.
OWB · Interventional Fluoroscopic X-ray System · 13d
Cleared Aug 10, 2011
RALCO
K110856 · Ralco S.R.L.
IZX · Collimator, Manual, Radiographic · 135d
Cleared Aug 10, 2011
RADIOLOGICAL IMAGE PROCESSING SYSTEM
K102078 · VATECH Co., Ltd.
LLZ · System, Image Processing, Radiological · 380d
Cleared Aug 05, 2011
INFINIX CF-I/SP AND INFINIX VF-I/SP MODEL INFX-8000V
K112054 · Toshiba Medical Systems Corporation, Japan
JAA · System, X-ray, Fluoroscopic, Image-intensified · 17d
Cleared Aug 05, 2011
IMPAX NEXT GENERATION
K111945 · Agfa Healthcare N.V.
LLZ · System, Image Processing, Radiological · 28d
Cleared Aug 05, 2011
GLIASITE RTS
K111931 · Isoray Medical, Inc.
KXK · Source, Brachytherapy, Radionuclide · 28d

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All categories 12612 LLZ System, Image Processing, Radiological 1997 IYN System, Imaging, Pulsed Doppler, Ultrasonic 1115 LNH System, Nuclear Magnetic Resonance Imaging 989 JAK System, X-ray, Tomography, Computed 742 IYO System, Imaging, Pulsed Echo, Ultrasonic 671 IYE Accelerator, Linear, Medical 567 MOS Coil, Magnetic Resonance, Specialty 447 MQB Solid State X-ray Imager (flat Panel/digital Imager) 407 KPS System, Tomography, Computed, Emission 384 ITX Transducer, Ultrasonic, Diagnostic 338 QIH Automated Radiological Image Processing Software 320 OWB Interventional Fluoroscopic X-ray System 307 KPR System, X-ray, Stationary 286 MUJ System, Planning, Radiation Therapy Treatment 227 JAA System, X-ray, Fluoroscopic, Image-intensified 190