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
12883 Radiology devices
10776–10800 of 12883
Cleared Dec 23, 1994
TUNGSTEN EYESHIELD
K943011 · Medtec, Inc.
IWS · Shield, Eye, Radiological · 182d
Cleared Dec 23, 1994
FIELD ABUTMENT WEDGE
K943343 · Medtec, Inc.
IXI · Block, Beam-shaping, Radiation Therapy · 164d
Cleared Dec 22, 1994
MAGNETIC RESONANCE DIAGNOSTIC ACCESSORY
K944112 · GE Medical Systems
LNH · System, Nuclear Magnetic Resonance Imaging · 121d
Cleared Dec 15, 1994
MERIT (O.1T MR SYSTEM)
K943415 · Philips Medical Systems (Cleveland), Inc.
LNH · System, Nuclear Magnetic Resonance Imaging · 153d
Cleared Dec 14, 1994
NRF SYSTEM
K944973 · Philips Medical Systems (Cleveland), Inc.
JAA · System, X-ray, Fluoroscopic, Image-intensified · 64d
Cleared Dec 14, 1994
PHILIPS BUCKY DIAGNOST FAMILY
K945278 · Philips Medical Systems North America, Inc.
KPR · System, X-ray, Stationary · 47d
Cleared Dec 09, 1994
MODEL 37-720 DUAL DIODE DOSIMETRY SYSTEM
K940660 · Victoreen, Inc.
IYE · Accelerator, Linear, Medical · 297d
Cleared Dec 09, 1994
VERSION 5 OPERATING SYSTEM SOFTWARE
K943799 · Hitachi Medical Systems America, Inc.
LNH · System, Nuclear Magnetic Resonance Imaging · 128d
Cleared Dec 09, 1994
TOMO-LINK
K944967 · GE Medical Systems
IZF · System, X-ray, Tomographic · 59d
Cleared Dec 09, 1994
COMPAS
K945483 · General Electric Co.
IZI · System, X-ray, Angiographic · 31d
Cleared Dec 08, 1994
PHILIPS ULTRASOUND P800 IMAGING SYSTEM
K935923 · Hewlett-Packard Co.
IYN · System, Imaging, Pulsed Doppler, Ultrasonic · 360d
Cleared Dec 07, 1994
DIAGNOSTIC ULTRASOUND IMAGING CATHETER
K940108 · Boston Scientific Corp
ITX · Transducer, Ultrasonic, Diagnostic · 331d
Cleared Dec 07, 1994
MOTORIZED DEPTH DOSE APPARATUS
K943199 · Medtec, Inc.
IYE · Accelerator, Linear, Medical · 155d
Cleared Dec 07, 1994
HP BACK POINTER SYSTEM
K943802 · Medtec, Inc.
IWE · Monitor, Patient Position, Light-beam · 125d
Cleared Nov 30, 1994
URO - ELITE TABLE ACCESSORIES
K944987 · Philips Medical Systems (Cleveland), Inc.
IXR · Table, Radiographic, Tilting · 49d
Cleared Nov 29, 1994
ADVANCE ANALYSIS SOFTWARE
K941223 · General Electric Co.
KPS · System, Tomography, Computed, Emission · 260d
Cleared Nov 29, 1994
HEAD AND NECK COIL FOR THE GYREX 2T-DLX
K943320 · Elscint, Inc.
LNH · System, Nuclear Magnetic Resonance Imaging · 141d
Cleared Nov 29, 1994
MEDRAD COUNTERPOISE SYSTEM
K944983 · Medrad, Inc.
JAK · System, X-ray, Tomography, Computed · 49d
Cleared Nov 28, 1994
V-MAX OPTIONS
K943447 · Philips Medical Systems (Cleveland), Inc.
JAA · System, X-ray, Fluoroscopic, Image-intensified · 133d
Cleared Nov 28, 1994
RAPIDO 2000 AUTOMATIC RADIOGRAPHIC TABLE
K943926 · Philips Medical Systems (Cleveland), Inc.
IZZ · Table, Radiographic, Non-tilting, Powered · 108d
Cleared Nov 22, 1994
GYROSCAN T10-NT (RELEASE 4 SERIES SOFTWARE)
K940534 · Philips Medical Systems, Inc.
LNH · System, Nuclear Magnetic Resonance Imaging · 288d
Cleared Nov 22, 1994
INTERSPEC APOGEE RX400 ULTRASOUND IMAGING SYSTEM AND DOPPLER ULTRASOUND FLOWMETER
K940671 · Interspec, Inc.
ITX · Transducer, Ultrasonic, Diagnostic · 279d
Cleared Nov 22, 1994
BLOCKING TRAY
K944315 · Medtec, Inc.
IYE · Accelerator, Linear, Medical · 85d
Cleared Nov 14, 1994
SHIMASONIC SDU-400 ELECTRONIC LINEAR/CONVEX D.U.S.
K931021 · Shimadzu Medical Systems
IYO · System, Imaging, Pulsed Echo, Ultrasonic · 623d
Cleared Nov 07, 1994
MAGNETIC RESONANCE DIAG DEVICE MAGNETOM VISION (MODIF)
K940541 · Siemens Medical Solutions USA, Inc.
LNH · System, Nuclear Magnetic Resonance Imaging · 273d

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All categories 12883 LLZ System, Image Processing, Radiological 2047 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