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
9951–9975 of 12852
Cleared Oct 01, 1997
HELAX-VISIR
K972617 · Helax AB
IYE · Accelerator, Linear, Medical · 84d
Cleared Oct 01, 1997
MIRAGE
K972886 · Segami Corp., Inc.
LLZ · System, Image Processing, Radiological · 57d
Cleared Oct 01, 1997
NEEDLE GUIDE/GRID
K973362 · Protek Medical Products, Inc.
ITX · Transducer, Ultrasonic, Diagnostic · 23d
Cleared Sep 29, 1997
OPTIVIEW
K972520 · Optimed Technologies, Inc.
LLZ · System, Image Processing, Radiological · 84d
Cleared Sep 29, 1997
KINEMATIC POSITIONERS
K972704 · Ge Medical Systems, Inc.
LNH · System, Nuclear Magnetic Resonance Imaging · 73d
Cleared Sep 23, 1997
MULTISPECT 2 511 KEV COLLIMATOR
K972360 · Siemens Medical Solutions USA, Inc.
KPS · System, Tomography, Computed, Emission · 90d
Cleared Sep 23, 1997
IMNET DICOM NETWORK AGENT
K972366 · Imnet Systems, Inc.
LMD · System, Digital Image Communications, Radiological · 90d
Cleared Sep 23, 1997
ADVANTAGE WINDOWS VOLUME RENDERING OPTION
K972399 · Ge Medical Systems, Inc.
JAK · System, X-ray, Tomography, Computed · 89d
Cleared Sep 15, 1997
MAGNETIC RESONANCE DIAGNOSTIC SYSTEM
K972296 · Ge Medical Systems, Inc.
MOS · Coil, Magnetic Resonance, Specialty · 88d
Cleared Sep 15, 1997
SIEMENS ORTHOPHOS DS/DS CEPH
K972312 · Siemens AG
EHD · Unit, X-ray, Extraoral With Timer · 87d
Cleared Sep 15, 1997
2T PRESTIGE(100-6321-0107)/PRIVILEGE(100-6326-0102)/GYREX V-EP(100-6327-0101)
K972592 · Elscint, Inc.
MOS · Coil, Magnetic Resonance, Specialty · 66d
Cleared Sep 12, 1997
ORTHOPHOS PLUS AND ORTHOPHOS PLUS/CD
K972249 · Pelton & Crane Co.
EHD · Unit, X-ray, Extraoral With Timer · 88d
Cleared Sep 12, 1997
FCR FUJI COMPUTED RADIOGRAPHY DMS CRT IMAGE CONSOLE HI-C654 (FOR NETWORKS)
K972256 · Fujifilm Medical System U.S.A., Inc.
LLZ · System, Image Processing, Radiological · 88d
Cleared Sep 11, 1997
INFIMED DENTAL SYSTEM
K962422 · Infimed, Inc.
EHD · Unit, X-ray, Extraoral With Timer · 444d
Cleared Sep 11, 1997
KODAK DIGITAL SCIENCE (KDS) MEDICAL IMAGE AND INFORMATION LIBRARY (MIIL)
K972380 · Eastman Kodak Company
LMB · Device, Digital Image Storage, Radiological · 77d
Cleared Sep 11, 1997
CEILING MOUNTED LATERAL POSITIONER, MODEL NO. 6896.002
K972442 · Continental X-Ray Corp.
JAA · System, X-ray, Fluoroscopic, Image-intensified · 73d
Cleared Sep 10, 1997
MULTIDOS, QC6PLUS
K972211 · Ptw-New York Corp.
LHN · System, Radiation Therapy, Charged-particle, Medical · 90d
Cleared Sep 10, 1997
0.015CC PINPOINT IONIZATION CHAMBER, 0.005 CC PINPOINT IONIZATION CHAMBER
K972212 · Ptw-New York Corp.
LHN · System, Radiation Therapy, Charged-particle, Medical · 90d
Cleared Sep 08, 1997
LOGIQ 1000 DIAGNOSTIC ULTRSOUND SYSTEM
K960527 · GE Medical Systems
IYN · System, Imaging, Pulsed Doppler, Ultrasonic · 580d
Cleared Sep 08, 1997
DIGITIZER DIRECTOR (HSC025-01)
K972191 · Howtek, Inc.
LMD · System, Digital Image Communications, Radiological · 90d
Cleared Sep 08, 1997
LANTIS TREATSTATION
K972275 · Siemens Medical Solutions USA, Inc.
IYE · Accelerator, Linear, Medical · 82d
Cleared Sep 08, 1997
CEQUAL-QUANTITATIVE ANALYSIS FOR CARDIOLITE EXECUTING ON THE MEDASYS DIGITAL SYSTEMS COMPUTER
K972509 · Nuccardiac Software, Inc.
KPS · System, Tomography, Computed, Emission · 67d
Cleared Sep 05, 1997
P REFERENCE TPS (TREATMENT PLANNING SOFTWARE) 1.1
K970464 · Northwest Medical Physics Equipment, Inc.
IYE · Accelerator, Linear, Medical · 210d
Cleared Sep 05, 1997
IMATION SE-196 LASER IMAGER
K972163 · Imation Corp.
LMC · Camera, Multi Format, Radiological · 88d
Cleared Sep 05, 1997
SIDEXIS DIGITAL RADIOGRAPHY SYSTEM
K972168 · Pelton & Crane Co.
EHD · Unit, X-ray, Extraoral With Timer · 88d

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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