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
12933 Radiology devices
11751–11775 of 12933
Cleared Jan 04, 1990
MODEL 5070
K894855 · Medical Advances, Inc.
LNH · System, Nuclear Magnetic Resonance Imaging · 157d
Cleared Dec 22, 1989
MODEL SPINE SURVEYOR-PLUS
K896336 · Medical Advances, Inc.
LNH · System, Nuclear Magnetic Resonance Imaging · 49d
Cleared Dec 22, 1989
GE TARGET SERIES 2
K896353 · GE Medical Systems
KPQ · System, Simulation, Radiation Therapy · 46d
Cleared Dec 22, 1989
DU PONT XENOLITE(TM) RADIATION PROTECTION APPAREL
K896511 · E.I. Dupont DE Nemours & Co., Inc.
KPY · Shield, Protective, Personnel · 38d
Cleared Dec 21, 1989
MODIFIED QDR-1000 X-RAY BONE DENSITOMETER
K890999 · Hologic, Inc.
KGI · Densitometer, Bone · 297d
Cleared Dec 21, 1989
GYROVIEW HR HIGH RESOLUTION WORKSTATION
K896647 · Philips Medical Systems North America, Inc.
LNH · System, Nuclear Magnetic Resonance Imaging · 27d
Cleared Dec 14, 1989
SHIMADZU WHOLE BODY X-RAY CT SCANNER SCT-3000TF
K894887 · Shimadzu Medical Systems
JAK · System, X-ray, Tomography, Computed · 135d
Cleared Dec 14, 1989
CIVCO LATEX ULTRASOUND SHEATHS
K895614 · CIVCO Medical Instruments Co., Inc.
IYO · System, Imaging, Pulsed Echo, Ultrasonic · 86d
Cleared Dec 14, 1989
GYROSCAN T5 MOBILE
K895869 · Philips Medical Systems, Inc.
LNH · System, Nuclear Magnetic Resonance Imaging · 71d
Cleared Dec 14, 1989
FUJI COMPUTED RADIOGRAPHY SYSTEM FCR AC-1 (FCR)
K896050 · Fujifilm Medical System U.S.A., Inc.
LLZ · System, Image Processing, Radiological · 57d
Cleared Nov 30, 1989
MAGNETOM M, H, 42, 63, 42 SP AND 63 SP
K895966 · Siemens Medical Solutions USA, Inc.
LNH · System, Nuclear Magnetic Resonance Imaging · 50d
Cleared Nov 22, 1989
RADIUS CF
K894547 · General Electric Co.
ITX · Transducer, Ultrasonic, Diagnostic · 125d
Cleared Nov 21, 1989
GAMMAMED IRIDIUM-192 SOURCE
K894381 · Mick Radio-Nuclear Instruments, Inc.
JAQ · System, Applicator, Radionuclide, Remote-controlled · 127d
Cleared Nov 17, 1989
ORTHOPHOS AND ORTHOPHOS C
K895467 · Siemens Medical Solutions USA, Inc.
EHD · Unit, X-ray, Extraoral With Timer · 67d
Cleared Nov 17, 1989
GE MR MAX SYSTEM
K895794 · GE Medical Systems
LNH · System, Nuclear Magnetic Resonance Imaging · 50d
Cleared Nov 15, 1989
POSITRON EMISSION COMPUTED TOMOGRAPH SET-1400W
K894056 · Shimadzu Medical Systems
KPS · System, Tomography, Computed, Emission · 161d
Cleared Nov 15, 1989
DIGICAM LHP (VIDEO INTERFACE OPTION)
K895668 · Siemens Gammasonics, Inc.
LMC · Camera, Multi Format, Radiological · 56d
Cleared Nov 13, 1989
MOBILE X-RAY TELEVISION UNIT WHA-10A/B
K895394 · Shimadzu Corp.
JAA · System, X-ray, Fluoroscopic, Image-intensified · 68d
Cleared Nov 06, 1989
SMT-50A MAGNETIC RESONANCE IMAGING SYSTEM
K893744 · Shimadzu Medical Systems
LNH · System, Nuclear Magnetic Resonance Imaging · 172d
Cleared Nov 06, 1989
ULTRANET-S COLLIMATOR
K894142 · GE Medical Systems
IZW · Collimator, Automatic, Radiographic · 146d
Cleared Nov 06, 1989
X-RAY EQUIPMENT (VARIOUS TYPES)
K895730 · Continental X-Ray Corp.
JAA · System, X-ray, Fluoroscopic, Image-intensified · 45d
Cleared Oct 30, 1989
VISTA MR 2055 HP SYSTEM
K895151 · Philips Medical Systems (Cleveland), Inc.
LNH · System, Nuclear Magnetic Resonance Imaging · 81d
Cleared Oct 27, 1989
MT/S SOFTWARE RELEASE 5.0.
K893518 · Diasonics, Inc.
LNH · System, Nuclear Magnetic Resonance Imaging · 172d
Cleared Oct 27, 1989
MODEL 2031 TMJ SURFACE COIL
K895131 · Medical Advances, Inc.
LNH · System, Nuclear Magnetic Resonance Imaging · 71d
Cleared Oct 13, 1989
SRI 100 RADIOTHERAPY IMAGING SYSTEM
K894912 · Philips Medical Systems, Inc.
IYE · Accelerator, Linear, Medical · 72d

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All categories 12933 LLZ System, Image Processing, Radiological 2054 IYN System, Imaging, Pulsed Doppler, Ultrasonic 1138 LNH System, Nuclear Magnetic Resonance Imaging 1002 JAK System, X-ray, Tomography, Computed 754 IYO System, Imaging, Pulsed Echo, Ultrasonic 691 IYE Accelerator, Linear, Medical 590 MOS Coil, Magnetic Resonance, Specialty 461 MQB Solid State X-ray Imager (flat Panel/digital Imager) 417 KPS System, Tomography, Computed, Emission 390 ITX Transducer, Ultrasonic, Diagnostic 348 QIH Automated Radiological Image Processing Software 329 OWB Interventional Fluoroscopic X-ray System 315 KPR System, X-ray, Stationary 297 MUJ System, Planning, Radiation Therapy Treatment 239 MUH System, X-ray, Extraoral Source, Digital 194