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
12869 Radiology devices
10276–10300 of 12869
Cleared Nov 12, 1996
BIAD NUCLEAR IMAGING SYSTEM
K964266 · Trionix Research Laboratory, Inc.
KPS · System, Tomography, Computed, Emission · 19d
Cleared Nov 12, 1996
MONAD NUCLEAR IMAGING SINGLE PHOTON EMISSION COMPUTED TOMOGRAPHY SYSTEM
K964267 · Trionix Research Laboratory, Inc.
KPS · System, Tomography, Computed, Emission · 19d
Cleared Nov 12, 1996
TRIAD 88 NUCLEAR IMAGING SYSTEM
K964268 · Trionix Research Laboratory, Inc.
KPS · System, Tomography, Computed, Emission · 19d
Cleared Nov 08, 1996
THERAPLAN PLUS
K954679 · Theratronics, Inc.
IYE · Accelerator, Linear, Medical · 395d
Cleared Nov 08, 1996
CODONICS MEDICAL PRINTER (NP-1600M,NP1600MD)
K962364 · Codonics, Inc.
LMC · Camera, Multi Format, Radiological · 142d
Cleared Nov 08, 1996
GAMMACELL 3000 ELAN, VERSION 1.0 AND GAMMACELL 1000 ELITE, VERSION 1.0
K963497 · Nordion International, Inc.
MOT · Irradiator, Blood To Prevent Graft Versus Host Disease · 66d
Cleared Nov 08, 1996
SHIMADZU X-RAY DIAGNOSTIC TABLE YSF-120
K963617 · Shimadzu Medical Systems
JAA · System, X-ray, Fluoroscopic, Image-intensified · 59d
Cleared Nov 07, 1996
CASS SYSTEM (MODIFICATION)
K961484 · Medical Instrumentation & Diagnostics Corp.(Midco)
IYE · Accelerator, Linear, Medical · 223d
Cleared Nov 07, 1996
MAGNETIC RESONANCE DIAGNOSTIC SYSTEM
K963179 · GE Medical Systems
LNH · System, Nuclear Magnetic Resonance Imaging · 85d
Cleared Nov 07, 1996
IMAGESHARE PROTOCOL CONVERTING GATEWAY AND/OR SOFTWARE [OS/2 WARP] 1OOO,[SUN/SOLARIS] 2000
K963592 · Dejarnette Research Systems
LMD · System, Digital Image Communications, Radiological · 59d
Cleared Nov 07, 1996
IMAGESHARE SECONDARY CAPTURE ACQUISITION STATION AND/OR SOFTWARE (1000 FILM DIGITIZER ACQUISITION STATION)
K963594 · Dejarnette Research Systems
LMD · System, Digital Image Communications, Radiological · 59d
Cleared Nov 07, 1996
IMAGESHARE COMPUTED RADIOGRAPHY ACQUISITION STATION AND/OR SOFTWARE
K963628 · Dejarnette Research Systems
LMD · System, Digital Image Communications, Radiological · 57d
Cleared Nov 07, 1996
FIBRE INTERSPACED X-RAY GRID
K963893 · Smit Rontgen
IXJ · Grid, Radiographic · 41d
Cleared Nov 07, 1996
EXPERT-KL AND HAND ACQUISITION AND ANALYSIS SOFTWARE
K964263 · Lunar Corp.
KGI · Densitometer, Bone · 13d
Cleared Oct 31, 1996
V-LINK 3.2 FOR WINDOWS
K963274 · Koven Technology, Inc.
IYO · System, Imaging, Pulsed Echo, Ultrasonic · 72d
Cleared Oct 29, 1996
SONOLINE ELEGRA WITH SIESCAPE FEATURE
K961833 · Siemens Medical Solutions USA, Inc.
IYO · System, Imaging, Pulsed Echo, Ultrasonic · 169d
Cleared Oct 29, 1996
HELAX TMS BRACHYTHERAPY, VERSION 3.0
K962892 · Siemens Medical Solutions USA, Inc.
LNH · System, Nuclear Magnetic Resonance Imaging · 97d
Cleared Oct 28, 1996
GAMMACON IMAGE TRANSLATION SYSTEM
K962955 · Medical Imaging Technology Assoc., Inc.
KPS · System, Tomography, Computed, Emission · 90d
Cleared Oct 28, 1996
FUJI MEDICAL DRY IMAGER FM-DP 2636
K962967 · Fujifilm Medical System U.S.A., Inc.
LMC · Camera, Multi Format, Radiological · 90d
Cleared Oct 25, 1996
CARDIOMETICS FLOWIRE, SMARTWIRE DOPPLER GUIDE WIRE
K951567 · Cardio Metrics, Inc.
ITX · Transducer, Ultrasonic, Diagnostic · 570d
Cleared Oct 25, 1996
SLS-CT
K960985 · Bio-Imaging Research, Inc.
JAK · System, X-ray, Tomography, Computed · 239d
Cleared Oct 25, 1996
VIEWSEND MEDICAL MODEL 1200
K962225 · Klt Telecom, Inc.
LMD · System, Digital Image Communications, Radiological · 137d
Cleared Oct 25, 1996
OPART MRT-600
K962933 · Toshiba America Mri, Inc.
LNH · System, Nuclear Magnetic Resonance Imaging · 88d
Cleared Oct 25, 1996
IMAGESERVER 2000 PICTURE ARCHIVING SYSTEM
K963395 · Sectra-Imtec AB
LMB · Device, Digital Image Storage, Radiological · 58d
Cleared Oct 18, 1996
FLEXART TMJ COIL
K961624 · Toshiba America Mri, Inc.
LNH · System, Nuclear Magnetic Resonance Imaging · 175d

Looking for a specific radiology device? Search by device name, K-number or manufacturer.

Search all Radiology 510(k) devices

Filter by Product Code

All categories 12869 LLZ System, Image Processing, Radiological 2045 IYN System, Imaging, Pulsed Doppler, Ultrasonic 1134 LNH System, Nuclear Magnetic Resonance Imaging 998 JAK System, X-ray, Tomography, Computed 750 IYO System, Imaging, Pulsed Echo, Ultrasonic 689 IYE Accelerator, Linear, Medical 588 MOS Coil, Magnetic Resonance, Specialty 460 MQB Solid State X-ray Imager (flat Panel/digital Imager) 417 KPS System, Tomography, Computed, Emission 387 ITX Transducer, Ultrasonic, Diagnostic 347 QIH Automated Radiological Image Processing Software 320 OWB Interventional Fluoroscopic X-ray System 315 KPR System, X-ray, Stationary 296 MUJ System, Planning, Radiation Therapy Treatment 238 MUH System, X-ray, Extraoral Source, Digital 193