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
12803 Radiology devices
9101–9125 of 12803
Cleared Apr 11, 2000
MULTI PURPOSE FLEX ARRAY COIL : MODEL 235 SERIES
K000345 · Medical Advances, Inc.
MOS · Coil, Magnetic Resonance, Specialty · 68d
Cleared Apr 07, 2000
MINXRAY HF70D HIGH FREQUENCY PORTABLE DENTAL X-RAY UNIT
K000061 · Minxray, Inc.
EHD · Unit, X-ray, Extraoral With Timer · 88d
Cleared Apr 07, 2000
KFA-63 KNEE AND FOOT ARRAY
K000935 · Mri Devices Corp.
MOS · Coil, Magnetic Resonance, Specialty · 15d
Cleared Apr 07, 2000
ADAC PINNACLE3TM RADIATION THERAPY PLANNING SYSTEM
K993923 · Adac Laboratories
MUJ · System, Planning, Radiation Therapy Treatment · 141d
Cleared Apr 05, 2000
SKYLIGHT IMAGING SYSTEM
K000908 · Adac Laboratories
KPS · System, Tomography, Computed, Emission · 15d
Cleared Mar 31, 2000
DIMEX 2
K000454 · Planmeca Oy
MUH · System, X-ray, Extraoral Source, Digital · 49d
Cleared Mar 31, 2000
RTLX
K992392 · Infimed, Inc.
MUH · System, X-ray, Extraoral Source, Digital · 256d
Cleared Mar 31, 2000
ISOSEED PD-103
K993552 · Bebig Isotopentechnik GmbH
KXK · Source, Brachytherapy, Radionuclide · 163d
Cleared Mar 29, 2000
BARCO MWD 321 PLUS MEDICAL WORKSTATION DISPLAY
K000292 · Barco N.V.
LLZ · System, Image Processing, Radiological · 58d
Cleared Mar 29, 2000
BARCO MGD 221 2 MEGAPIXEL DIAGNOSTIC DISPLAY
K000293 · Barco N.V.
LLZ · System, Image Processing, Radiological · 58d
Cleared Mar 29, 2000
EUB-6000 ULTRASOUND DIAGNOSTIC SCANNER
K994026 · Hitachi Medical Corp. of America
IYN · System, Imaging, Pulsed Doppler, Ultrasonic · 124d
Cleared Mar 27, 2000
MFCD 118
K000291 · Barco N.V.
LLZ · System, Image Processing, Radiological · 56d
Cleared Mar 27, 2000
MFCD 120
K000294 · Barco N.V.
LLZ · System, Image Processing, Radiological · 56d
Cleared Mar 27, 2000
VENTRICULAR ANALYSIS TOOLKIT OPTION
K000315 · GE Medical Systems
LNH · System, Nuclear Magnetic Resonance Imaging · 55d
Cleared Mar 27, 2000
MLC FIT
K991133 · Impac Medical Systems, Inc.
IYE · Accelerator, Linear, Medical · 360d
Cleared Mar 27, 2000
SONOGRAPHIC PLANNING OF ONCOLOGY TREATMENTS (SPOT), MODEL V.. 1.0
K992303 · Nucletron Corp.
MUJ · System, Planning, Radiation Therapy Treatment · 263d
Cleared Mar 27, 2000
MCA-601, C-ARM MOBILE
K993896 · Medison Radiology Systems, Inc.
JAA · System, X-ray, Fluoroscopic, Image-intensified · 132d
Cleared Mar 24, 2000
HDI 1500/SA 8800 ULTRASOUND SYSTEM WITH MULTIPLANE TRANSESOPHAGEAL ULTRASOUND TRANSDUCER (MTP7-4)
K994373 · Atl Ultrasound, Inc.
ITX · Transducer, Ultrasonic, Diagnostic · 88d
Cleared Mar 23, 2000
SHIMADZU WHOLE BODY X-RAY COMPUTED TOMOGRAPHY SCANNER SCT-7800 SERIES
K994431 · Shimadzu Medical Systems
JAK · System, X-ray, Tomography, Computed · 84d
Cleared Mar 22, 2000
M.R. VISION 2000 ULTRA AUDIO VISUAL SYSTEM / COMMANDER X6 SYSTEM
K994351 · Resonance Technology, Inc.
LNH · System, Nuclear Magnetic Resonance Imaging · 90d
Cleared Mar 22, 2000
RADIOCAMERAS SYSTEM HEAD/NECK APPLICATION
K994355 · Surgical Navigation Technologies, Inc.
IYE · Accelerator, Linear, Medical · 90d
Cleared Mar 21, 2000
I-PLANT, MODEL 3500
K994317 · Implant Sciences Corp.
KXK · Source, Brachytherapy, Radionuclide · 90d
Cleared Mar 16, 2000
GE DOLPHIN DIAGNOSTIC ULTRASOUND SYSTEM, ULTRASONIC PULSED DOPPLER IMAGING SYSTEM
K000695 · Ge Medical Systems, Inc.
IYO · System, Imaging, Pulsed Echo, Ultrasonic · 15d
Cleared Mar 16, 2000
125-IMPLANT SEEDS, MODEL STM1250
K991881 · Sourcetech Medical, LLC
KXK · Source, Brachytherapy, Radionuclide · 288d
Cleared Mar 16, 2000
FONAR 360 DEGREE MAGNETIC RESONANCE IMAGING SCANNER
K994287 · Fonar Corp.
LNH · System, Nuclear Magnetic Resonance Imaging · 87d

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 12803 LLZ System, Image Processing, Radiological 2033 IYN System, Imaging, Pulsed Doppler, Ultrasonic 1127 LNH System, Nuclear Magnetic Resonance Imaging 997 JAK System, X-ray, Tomography, Computed 747 IYO System, Imaging, Pulsed Echo, Ultrasonic 685 IYE Accelerator, Linear, Medical 585 MOS Coil, Magnetic Resonance, Specialty 456 MQB Solid State X-ray Imager (flat Panel/digital Imager) 411 KPS System, Tomography, Computed, Emission 387 ITX Transducer, Ultrasonic, Diagnostic 347 QIH Automated Radiological Image Processing Software 320 OWB Interventional Fluoroscopic X-ray System 313 KPR System, X-ray, Stationary 294 MUJ System, Planning, Radiation Therapy Treatment 236 MUH System, X-ray, Extraoral Source, Digital 192