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
12720 Radiology devices
7551–7575 of 12720
Cleared Aug 18, 2006
HD11 DIAGNOSTIC ULTRASOUND SYSTEM
K062247 · Philips Ultrasound, Inc.
IYN · System, Imaging, Pulsed Doppler, Ultrasonic · 15d
Cleared Aug 17, 2006
MICROSELECTRON V3, MODEL 106.990
K061354 · Nucletron Corporation
JAQ · System, Applicator, Radionuclide, Remote-controlled · 94d
Cleared Aug 17, 2006
XAMINER
K061595 · Imaging Dynamics Company , Ltd.
KPR · System, X-ray, Stationary · 70d
Cleared Aug 17, 2006
SIEMENS ACUSON X500 ULTRASOUND SYSTEM
K061980 · Siemens Medical Solutions USA, Inc.
IYN · System, Imaging, Pulsed Doppler, Ultrasonic · 35d
Cleared Aug 17, 2006
CXDI-40EC
K062221 · Canon, Inc.
MQB · Solid State X-ray Imager (flat Panel/digital Imager) · 15d
Cleared Aug 15, 2006
FAXITRON DIGITAL RADIOGRAPHY SYSTEM, MODEL DX-50
K061361 · Faxitron X-Ray Corp.
MWP · Cabinet, X-ray System · 91d
Cleared Aug 15, 2006
9900 PLUS MOBILE FLUOROSCOPY SYSTEM WITH 3D AND NAVIGATION OPTIONS
K061953 · Ge Oec Medical Systems
OWB · Interventional Fluoroscopic X-ray System · 36d
Cleared Aug 15, 2006
DRY LASER IMAGER, DRYPRO MODEL 832
K061999 · Konica Minolta Medical & Graphic, Inc.
LMC · Camera, Multi Format, Radiological · 32d
Cleared Aug 11, 2006
NEURO II-SE, MODELS OR-MB-DR AND OR-DR
K061916 · Imris, Inc.
LNH · System, Nuclear Magnetic Resonance Imaging · 36d
Cleared Aug 10, 2006
VOLCANO S51 FAMILY OF IMAGING SYSTEMS
K061215 · Volcano Corporation
IYO · System, Imaging, Pulsed Echo, Ultrasonic · 100d
Cleared Aug 10, 2006
NEUROQUANT
K061855 · Cortechs Labs, Inc.
LLZ · System, Image Processing, Radiological · 41d
Cleared Aug 10, 2006
VITAL CONNECT 4.0
K062154 · Vital Images, Inc.
LLZ · System, Image Processing, Radiological · 13d
Cleared Aug 07, 2006
MYLAB15/20 NEW INDICATIONS ULTRASOUND SYSTEM
K061755 · Esaote Europe B.V.
IYO · System, Imaging, Pulsed Echo, Ultrasonic · 47d
Cleared Aug 07, 2006
MEDCHANNEL HTS SYSTEM
K061831 · Medchannel, LLC
IYN · System, Imaging, Pulsed Doppler, Ultrasonic · 40d
Cleared Aug 07, 2006
XCAT
K061834 · Xoran Technologies, Inc.
JAK · System, X-ray, Tomography, Computed · 39d
Cleared Aug 07, 2006
MONOCHROME LCD MONITOR, RADIFORCE, GS320
K062053 · Eizo Nanao Corporation
LLZ · System, Image Processing, Radiological · 18d
Cleared Aug 04, 2006
BEST STRAND AND BEST SPACER
K061638 · Best Medical International, Inc.
KXK · Source, Brachytherapy, Radionuclide · 53d
Cleared Aug 04, 2006
SONIX ULTRASOUND SCANNER
K061827 · Ultrasonix Medical Corporation
IYN · System, Imaging, Pulsed Doppler, Ultrasonic · 37d
Cleared Jul 28, 2006
CALYPSO 4D LOCALIZATION SYSTEM
K060906 · Calypso Medical Technologies, Inc.
IYE · Accelerator, Linear, Medical · 116d
Cleared Jul 28, 2006
BIOLUCENT APPLICATOR, MODEL RTA-XX
K061241 · Biolucent, Inc.
JAQ · System, Applicator, Radionuclide, Remote-controlled · 86d
Cleared Jul 28, 2006
DIAGNOSOFT HARP
K061368 · Diagnosoft, Inc.
LNH · System, Nuclear Magnetic Resonance Imaging · 73d
Cleared Jul 28, 2006
HIP STRUCTURAL ANALYSIS SOFTWARE OPTION FOR THE HOLOGIC QDR X-RAY BONE DENSITOMETERS
K061561 · Hologic, Inc.
KGI · Densitometer, Bone · 53d
Cleared Jul 28, 2006
MRGFUS GENERAL PURPOSE AND BREAST COIL
K061715 · Insightec Txsonics, Inc.
MOS · Coil, Magnetic Resonance, Specialty · 39d
Cleared Jul 28, 2006
IBA PROTON THERAPY SYSTEM - PROTEUS 235
K061913 · Ion Beam Applications S.A.
LHN · System, Radiation Therapy, Charged-particle, Medical · 22d
Cleared Jul 28, 2006
INDOMITABLE MAGNETIC RESONANCE IMAGING SCANNER ACCESSORY
K061930 · Fonar Corp.
LNH · System, Nuclear Magnetic Resonance Imaging · 21d

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All categories 12720 LLZ System, Image Processing, Radiological 2018 IYN System, Imaging, Pulsed Doppler, Ultrasonic 1117 LNH System, Nuclear Magnetic Resonance Imaging 995 JAK System, X-ray, Tomography, Computed 747 IYO System, Imaging, Pulsed Echo, Ultrasonic 679 IYE Accelerator, Linear, Medical 576 MOS Coil, Magnetic Resonance, Specialty 453 MQB Solid State X-ray Imager (flat Panel/digital Imager) 409 KPS System, Tomography, Computed, Emission 384 ITX Transducer, Ultrasonic, Diagnostic 344 QIH Automated Radiological Image Processing Software 320 OWB Interventional Fluoroscopic X-ray System 312 KPR System, X-ray, Stationary 288 MUJ System, Planning, Radiation Therapy Treatment 233 MUH System, X-ray, Extraoral Source, Digital 190