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
12852 Radiology devices
9926–9950 of 12852
Cleared Oct 23, 1997
BANG POLYMER GEL DOSIMETER, BANG 533
K972804 · Mgs Research, Inc.
IYE · Accelerator, Linear, Medical · 87d
Cleared Oct 17, 1997
STRAIT'MAP OPTION
K973368 · Ge Medical Systems, Inc.
IZI · System, X-ray, Angiographic · 39d
Cleared Oct 16, 1997
IMAGEVIEW CORONARY ANGIOGRAPHY DISPLAY AND REVIEW SYSTEM
K972229 · Heartware, Inc.
IZI · System, X-ray, Angiographic · 125d
Cleared Oct 16, 1997
TBI STAND
K972709 · Mick Radio-Nuclear Instruments, Inc.
IYE · Accelerator, Linear, Medical · 87d
Cleared Oct 16, 1997
LEGACY/LEGACY-D TABLE
K973039 · GE Medical Systems
IXR · Table, Radiographic, Tilting · 63d
Cleared Oct 16, 1997
DRTS REMOTE CONTROL DRAPE
K973067 · Minrad, Inc.
JAA · System, X-ray, Fluoroscopic, Image-intensified · 59d
Cleared Oct 15, 1997
ESTEEM 1.5T MRI SYSTEM
K972826 · Elscint Mr, Inc.
LNH · System, Nuclear Magnetic Resonance Imaging · 78d
Cleared Oct 15, 1997
ULTRAFAST CT SCANNER
K972879 · Imatron, Inc.
JAK · System, X-ray, Tomography, Computed · 71d
Cleared Oct 15, 1997
PERCEPTION INC. GPS-TUV DIAGNOSTIC ULTRASOUND SYSTEM
K972973 · Perception, Inc.
IYO · System, Imaging, Pulsed Echo, Ultrasonic · 65d
Cleared Oct 14, 1997
VCAR OPTION TO THE DST AND DST-XL GAMMA CAMERAS AND VISION POWERSTATION COMPUTER
K972686 · Smv America
KPS · System, Tomography, Computed, Emission · 89d
Cleared Oct 09, 1997
DISPOSABLE CAMERA COVER, ENCLOSED: DISPOSABLE CAMERA COVER, PERFORATED: DISPOSABLE MICROSCOPE COVER (VARIOUS):X-RAY COVR
K972130 · Fairmontmedical
IZJ · Camera, X-ray, Fluorographic, Cine Or Spot · 125d
Cleared Oct 08, 1997
MD100 & MM150
K963913 · Konica Medical Corp.
EAM · Screen, Intensifying, Radiographic · 373d
Cleared Oct 08, 1997
CM & CM DS-7
K963914 · Konica Medical Corp.
IXA · Cassette, Radiographic Film · 373d
Cleared Oct 08, 1997
ACU-RAY HF SERIES PORTABLE X-RAY UNIT
K972204 · Sterne Equipment Co., Ltd.
IZL · System, X-ray, Mobile · 118d
Cleared Oct 08, 1997
ROTOGRAPH PLUS
K972968 · Chicago X-Ray Systems, Inc.
EHD · Unit, X-ray, Extraoral With Timer · 58d
Cleared Oct 08, 1997
DRTS IMAGE INTENSIFIER DRAPE
K973073 · Minrad, Inc.
JAA · System, X-ray, Fluoroscopic, Image-intensified · 51d
Cleared Oct 08, 1997
MAMMOLOADER BY C.M.A. SRL
K973125 · C.M.A.
IXW · Processor, Radiographic-film, Automatic · 49d
Cleared Oct 08, 1997
AMBER DU
K973219 · Oldelft Corp. of America
KPR · System, X-ray, Stationary · 42d
Cleared Oct 08, 1997
SHIMADZU WHOLE BODY X-RAY COMPUTED TOMOGRAPHY SCANNER SCT-6800TH
K973327 · Shimadzu Medical Systems
JAK · System, X-ray, Tomography, Computed · 34d
Cleared Oct 08, 1997
SHIMADZU WHOLE BODY X-RAY COMPUTED TOMOGRAPHY SCANNER SCT-6800TX
K973329 · Shimadzu Medical Systems
JAK · System, X-ray, Tomography, Computed · 34d
Cleared Oct 08, 1997
DAR-3000B
K973342 · Shimadzu Corp.
IZI · System, X-ray, Angiographic · 33d
Cleared Oct 07, 1997
KODAK DIGITAL SCIENCE 9000D MEDICAL LASER PRINTER (9000D)
K972847 · Eastman Kodak Company
LMC · Camera, Multi Format, Radiological · 67d
Cleared Oct 03, 1997
GE LOGIQ 700 DIAGNOSTIC ULTRASOUND SYSTEM
K964617 · GE Medical Systems
IYO · System, Imaging, Pulsed Echo, Ultrasonic · 340d
Cleared Oct 03, 1997
EXPERT-XL TOTAL BODY ACQUISITION AND ANALYSIS SOFTWARE
K965226 · Lunar Corp.
KPS · System, Tomography, Computed, Emission · 277d
Cleared Oct 01, 1997
COLORPOINT OR PROFESSIONAL COLORPOINT
K971760 · Seiko Instruments USA, Inc.
LMC · Camera, Multi Format, Radiological · 142d

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All categories 12852 LLZ System, Image Processing, Radiological 2039 IYN System, Imaging, Pulsed Doppler, Ultrasonic 1133 LNH System, Nuclear Magnetic Resonance Imaging 998 JAK System, X-ray, Tomography, Computed 749 IYO System, Imaging, Pulsed Echo, Ultrasonic 687 IYE Accelerator, Linear, Medical 588 MOS Coil, Magnetic Resonance, Specialty 459 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