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
12868 Radiology devices
10126–10150 of 12868
Cleared Apr 16, 1997
STATNET
K970525 · Gorca Systems, Inc.
IZI · System, X-ray, Angiographic · 64d
Cleared Apr 15, 1997
EXL-12SP,12DP,15DP,20DP LINAC
K970137 · Mitsubishi Electronics America, Inc.
IYE · Accelerator, Linear, Medical · 90d
Cleared Apr 11, 1997
ISOCAM I (SINGLE HEAD GAMMA CAMERA)/ISOCAM II (DUAL HEAD GAMMA CAMERA)
K970128 · Park Medical Systems, Inc.
KPS · System, Tomography, Computed, Emission · 87d
Cleared Apr 07, 1997
DOWNSCAN 120
K970451 · Merlin Engineering Works, Inc.
LLZ · System, Image Processing, Radiological · 60d
Cleared Apr 04, 1997
KODAK EKTASIAN HG FILM (EHG-15)
K970154 · Eastman Kodak Company
IWZ · Film, Radiographic · 78d
Cleared Apr 04, 1997
IMEX FUTURALDOP PRO
K970156 · Imex Medical Systems, Inc.
IYO · System, Imaging, Pulsed Echo, Ultrasonic · 78d
Cleared Apr 04, 1997
PICTURE ARCHIVING & COMMUNICATIONS DEVICE
K970534 · Multimedia Solutions
LLZ · System, Image Processing, Radiological · 51d
Cleared Apr 04, 1997
COMPUTED TOMOGRAPHY X-RAY SYSTEM
K970606 · GE Medical Systems
JAK · System, X-ray, Tomography, Computed · 45d
Cleared Apr 03, 1997
CLINICAL PHOSPHORUS SPECTROSCOPY OPTION/MAGNETOM VISION SYSTEM
K962627 · Siemens Medical Solutions USA, Inc.
LNI · System, Nuclear Magnetic Resonance Spectroscopic · 272d
Cleared Apr 03, 1997
ALOKA SSD-1700 DIAGNOSTIC ULTRASOUND SYSTEM
K963616 · Aloka Co., Ltd.
IYN · System, Imaging, Pulsed Doppler, Ultrasonic · 205d
Cleared Apr 01, 1997
LINAC SCALPEL FLOORSTAND
K964517 · Surgical Navigation Technologies, Inc.
IYE · Accelerator, Linear, Medical · 140d
Cleared Apr 01, 1997
UPSCAN 120
K970450 · Merlin Engineering Works, Inc.
LLZ · System, Image Processing, Radiological · 54d
Cleared Apr 01, 1997
PROSTYLE INTRA
K970975 · Planmeca Oy
EHD · Unit, X-ray, Extraoral With Timer · 15d
Cleared Mar 31, 1997
ACCESSPOINT, MED E-MAIL, DICOM READER
K963936 · Biosound, Inc.
LMB · Device, Digital Image Storage, Radiological · 181d
Cleared Mar 31, 1997
E. CAM PROFILE ATTENUATION CORRECTION
K963983 · Siemens Corp.
KPS · System, Tomography, Computed, Emission · 178d
Cleared Mar 31, 1997
FUJI MEDICAL LASER IMAGER MF PRINT SERVER MF-PS667
K970349 · Fujifilm Medical System U.S.A., Inc.
LLZ · System, Image Processing, Radiological · 60d
Cleared Mar 28, 1997
BIO-BINKI
K961782 · Biomni Medical Systems, Inc.
JAA · System, X-ray, Fluoroscopic, Image-intensified · 324d
Cleared Mar 28, 1997
ARTOSCAN M
K963262 · Biosound, Inc.
LNH · System, Nuclear Magnetic Resonance Imaging · 220d
Cleared Mar 28, 1997
GYREX 2T-PRESTIGE
K970005 · Elscint, Inc.
LNI · System, Nuclear Magnetic Resonance Spectroscopic · 85d
Cleared Mar 26, 1997
LEVEL 10 HDI
K961459 · Advanced Technology Laboratories, Inc.
IYO · System, Imaging, Pulsed Echo, Ultrasonic · 344d
Cleared Mar 26, 1997
DOCTORS REVIEW SYSTEM
K970402 · Digisonics, Inc.
LLZ · System, Image Processing, Radiological · 51d
Cleared Mar 21, 1997
EPI-SCOPE OPTION FOR Q SERIES CT SYSTEMS
K962010 · Philips Medical Systems (Cleveland), Inc.
LLZ · System, Image Processing, Radiological · 302d
Cleared Mar 21, 1997
DECISION SUPPORT SYSTEM (FOR RADIATION ONCOLOGY)
K964167 · Multidata Systems International Corp.
IYE · Accelerator, Linear, Medical · 156d
Cleared Mar 21, 1997
FUJI COMPUTED RADIOGRAPHY FCR/DICOM GATEWAY UNIT CR-DM666
K970293 · Fujifilm Medical System U.S.A., Inc.
LMD · System, Digital Image Communications, Radiological · 56d
Cleared Mar 21, 1997
PHILIPS EASY DIAGNOST
K970640 · Philips Medical Systems North America, Inc.
IXR · Table, Radiographic, Tilting · 29d

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All categories 12868 LLZ System, Image Processing, Radiological 2044 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