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
10826–10850 of 12885
Cleared Sep 16, 1994
MT-300 CASSETTE HOLDER
K941600 · Medtec, Inc.
IXA · Cassette, Radiographic Film · 168d
Cleared Sep 16, 1994
MICRO X-50 HF
K944147 · Fischer Imaging Corp.
IZO · Generator, High-voltage, X-ray, Diagnostic · 22d
Cleared Sep 16, 1994
MICRO X-30HF
K944148 · Fischer Imaging Corp.
IZO · Generator, High-voltage, X-ray, Diagnostic · 22d
Cleared Sep 16, 1994
MICRO X-80 HF
K944149 · Fischer Imaging Corp.
IZO · Generator, High-voltage, X-ray, Diagnostic · 22d
Cleared Sep 16, 1994
MICRO X-65 HF
K944150 · Fischer Imaging Corp.
IZO · Generator, High-voltage, X-ray, Diagnostic · 22d
Cleared Sep 15, 1994
PHILIPS THORAVISION
K931071 · Philips Medical Systems, Inc.
KPR · System, X-ray, Stationary · 562d
Cleared Sep 14, 1994
MOBILETT PLUS MOBILE X-RAY SYSTEM
K932106 · Siemens Medical Solutions USA, Inc.
IZL · System, X-ray, Mobile · 499d
Cleared Sep 14, 1994
MAMMOMAT 300 AND MAMMOMAT 3000
K932672 · Siemens Medical Solutions USA, Inc.
IZH · System, X-ray, Mammographic · 469d
Cleared Sep 09, 1994
CINEMAC QAS
K936002 · Xre Corp.
IZI · System, X-ray, Angiographic · 268d
Cleared Sep 09, 1994
MAGNETIC RESONANCE DIAGNOSTIC DEVICE
K942560 · Hitachi Medical Systems America, Inc.
LNH · System, Nuclear Magnetic Resonance Imaging · 101d
Cleared Sep 02, 1994
MRT-150A SHOULDER COIL
K942609 · Toshiba America Mri, Inc.
LNH · System, Nuclear Magnetic Resonance Imaging · 92d
Cleared Aug 25, 1994
EDGE
K941996 · Philips Medical Systems (Cleveland), Inc.
LNH · System, Nuclear Magnetic Resonance Imaging · 122d
Cleared Aug 24, 1994
GYREX 2T-SGR
K935549 · Elscint, Inc.
LNH · System, Nuclear Magnetic Resonance Imaging · 280d
Cleared Aug 23, 1994
ADVANCED AUTOMATIC KV
K934831 · Elscint, Inc.
IZH · System, X-ray, Mammographic · 319d
Cleared Aug 23, 1994
HISPEED ADVANTAGE II
K940606 · GE Medical Systems
JAK · System, X-ray, Tomography, Computed · 194d
Cleared Aug 23, 1994
ACCESS
K940796 · Toshiba America Mri, Inc.
LNH · System, Nuclear Magnetic Resonance Imaging · 182d
Cleared Aug 23, 1994
IMEXDOP CT+
K942441 · Imex Medical Systems, Inc.
JAF · Monitor, Ultrasonic, Nonfetal · 92d
Cleared Aug 22, 1994
VASCULAR MP X-RAY GENERATOR
K943652 · GE Medical Systems
IZO · Generator, High-voltage, X-ray, Diagnostic · 25d
Cleared Aug 22, 1994
KYOKKO SPEC-SERIES INTENSIFY SCREENS-SPEC,SUPER SPEC
K943821 · Fujifilm Medical System U.S.A., Inc.
EAM · Screen, Intensifying, Radiographic · 68d
Cleared Aug 22, 1994
FUJI UM MAMMO SERIES INTENSIFY SCREENS:
K943822 · Fujifilm Medical System U.S.A., Inc.
EAM · Screen, Intensifying, Radiographic · 68d
Cleared Aug 22, 1994
FUJI FG SERIES INTENSIFYING SCREENS: FG-3-4-8-12
K943823 · Fujifilm Medical System U.S.A., Inc.
EAM · Screen, Intensifying, Radiographic · 68d
Cleared Aug 17, 1994
CARDIOMETRICS FLOMAP AND FLOMOD ULTRASOUND INSTRUMENT
K933320 · Cardio Metrics, Inc.
IYO · System, Imaging, Pulsed Echo, Ultrasonic · 406d
Cleared Aug 17, 1994
KODAK AUTOMIXER III INTEGRATED, KODAK AUTOMIXER III 180 LP
K940386 · Eastman Kodak Company
IXL · Device, Spot-film · 203d
Cleared Aug 17, 1994
COOK BRACH NEEDLE/RADIO DELIV CATH/FLEXI FLEXICATH
K940550 · Cook, Inc.
IWJ · System, Applicator, Radionuclide, Manual · 191d
Cleared Aug 17, 1994
VIDEO PLUS WITH ANALYTICAL WORKSTATION
K941979 · Camtronics, Ltd.
IZI · System, X-ray, Angiographic · 114d

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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