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

15668
Total
15649
Cleared
148d
Avg (2y)
1976
Since
12885 Radiology devices
10851–10875 of 12885
Cleared Aug 17, 1994
LINEAR TOMOGRAPHIC SYSTEM: PMT 6000
K942175 · Continental X-Ray Corp.
IZF · System, X-ray, Tomographic · 105d
Cleared Aug 17, 1994
KYOKKO GREEN SERIES INTENSIFYING SCREENS
K942235 · Fujifilm Medical System U.S.A., Inc.
EAM · Screen, Intensifying, Radiographic · 100d
Cleared Aug 17, 1994
FUJI HG-M INTENSIFYING SCREEN
K943425 · Fujifilm Medical System U.S.A., Inc.
EAM · Screen, Intensifying, Radiographic · 33d
Cleared Aug 17, 1994
RSX-525HF
K943504 · Fischer Imaging Corp.
IZO · Generator, High-voltage, X-ray, Diagnostic · 28d
Cleared Aug 09, 1994
VARIAN C/D-SERIES CLINACS (CLINAC 600 C/D)
K926321 · Varian Assoc., Inc.
IYE · Accelerator, Linear, Medical · 601d
Cleared Aug 09, 1994
LASER ALIGNMENT TOOL
K943381 · Philips Medical Systems North America, Inc.
IWE · Monitor, Patient Position, Light-beam · 27d
Cleared Jul 29, 1994
ANGIOCT OPTION FOR CT-TWIN, HELICAT & OMNIVIEW
K932508 · Elscint, Inc.
JAK · System, X-ray, Tomography, Computed · 430d
Cleared Jul 29, 1994
NUCLEAR ASSOC 37-08 SER, RAYCAST HP RADIO IMMOB SYST
K935435 · Victoreen, Inc.
IYE · Accelerator, Linear, Medical · 261d
Cleared Jul 29, 1994
NOVA MICROSONICS ACCESS IMAGE MANAGEMENT NETWORK/ACCESS ACQUISITION MODULE
K940423 · Advanced Technology Laboratories, Inc.
LMD · System, Digital Image Communications, Radiological · 179d
Cleared Jul 29, 1994
TSX-002A (XVISION) CT SCANNER
K941745 · Toshiba America Medical Systems, In.C
JAK · System, X-ray, Tomography, Computed · 113d
Cleared Jul 29, 1994
SNAC (SIEMENS NUCLEAR ACQUISITION COMPUTER)
K942116 · Siemens Corp.
KPS · System, Tomography, Computed, Emission · 87d
Cleared Jul 29, 1994
FUJI ULTIMA EC-MA CASSETTE
K942481 · Fujifilm Medical System U.S.A., Inc.
IXA · Cassette, Radiographic Film · 65d
Cleared Jul 29, 1994
MODEL VPW2877F8, MAMMO 5 POWER SUPPLY
K942778 · Varian Assoc., Inc.
IZO · Generator, High-voltage, X-ray, Diagnostic · 46d
Cleared Jul 29, 1994
BUCKY STAND BR-10M
K942792 · Shimadzu Corp.
KPR · System, X-ray, Stationary · 45d
Cleared Jul 29, 1994
KYOKKO BLUE SERIES INTENSIFYING SCREENS
K942805 · Fujifilm Medical System U.S.A., Inc.
EAM · Screen, Intensifying, Radiographic · 44d
Cleared Jul 29, 1994
KODAK INSIGHT TWIN-LOAD INSERT
K942909 · Eastman Kodak Company
EAM · Screen, Intensifying, Radiographic · 38d
Cleared Jul 28, 1994
MERIT
K941408 · Philips Medical Systems (Cleveland), Inc.
LNH · System, Nuclear Magnetic Resonance Imaging · 127d
Cleared Jul 20, 1994
CRONEX REGULAR CASSETTE
K941475 · Dupont Medical Products
IXA · Cassette, Radiographic Film · 114d
Cleared Jul 18, 1994
UNI-FRAME HEAD IMMOBILIZATION SYSTEM
K933227 · Medtec, Inc.
IYE · Accelerator, Linear, Medical · 381d
Cleared Jul 18, 1994
VAC-LOK IMMOBILIZATION SYSTEM
K935300 · Medtec, Inc.
IYE · Accelerator, Linear, Medical · 258d
Cleared Jul 18, 1994
MED-TEC, INC. BREAST BOARD, MT-250
K935411 · Medtec, Inc.
IYE · Accelerator, Linear, Medical · 251d
Cleared Jul 18, 1994
MED-TEC, INC. BREAST BOARD, MT-200
K935412 · Medtec, Inc.
IYE · Accelerator, Linear, Medical · 251d
Cleared Jul 18, 1994
TEC 2101 (MODEL MT-HPLGD)
K941169 · Medtec, Inc.
IWE · Monitor, Patient Position, Light-beam · 126d
Cleared Jul 18, 1994
360 DEG. ROTATING 1/2 BEAM BLOCK
K941719 · Medtec, Inc.
IXI · Block, Beam-shaping, Radiation Therapy · 102d
Cleared Jul 18, 1994
ADVANTAGE WINDOWS DIAGNOSTIC X-RAY WORKSTATION
K942120 · GE Medical Systems
IZI · System, X-ray, Angiographic · 76d

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All categories 12885 LLZ System, Image Processing, Radiological 2048 IYN System, Imaging, Pulsed Doppler, Ultrasonic 1134 LNH System, Nuclear Magnetic Resonance Imaging 998 JAK System, X-ray, Tomography, Computed 751 IYO System, Imaging, Pulsed Echo, Ultrasonic 690 IYE Accelerator, Linear, Medical 589 MOS Coil, Magnetic Resonance, Specialty 460 MQB Solid State X-ray Imager (flat Panel/digital Imager) 417 KPS System, Tomography, Computed, Emission 388 ITX Transducer, Ultrasonic, Diagnostic 347 QIH Automated Radiological Image Processing Software 321 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