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
12832 Radiology devices
9276–9300 of 12832
Cleared Oct 15, 1999
QSC-085 SHOULDER ARRAY COIL
K993279 · Mri Devices Corp.
MOS · Coil, Magnetic Resonance, Specialty · 15d
Cleared Oct 13, 1999
RAYPAX WEB CLINICAL SYSTEM
K992426 · Samsung Sds Co., Ltd.
LMD · System, Digital Image Communications, Radiological · 84d
Cleared Oct 13, 1999
CANON X-RAY DIGITAL CAMERA, MODEL CXDI-22
K992547 · Canon USA, Inc.
MQB · Solid State X-ray Imager (flat Panel/digital Imager) · 75d
Cleared Oct 13, 1999
VIDEO PLUS SYSTEM, SERIES 95000
K992666 · Camtronics, Ltd.
LLZ · System, Image Processing, Radiological · 65d
Cleared Oct 12, 1999
SNT IMAGE ANALYSIS SYSTEM
K992354 · Surgical Navigation Technologies, Inc.
LLZ · System, Image Processing, Radiological · 90d
Cleared Oct 08, 1999
VIRGO MRI SYSTEM
K990153 · Millennium Technology Services
LNH · System, Nuclear Magnetic Resonance Imaging · 262d
Cleared Oct 08, 1999
AIRIS, AIRIS II
K992650 · Hitachi Medical Systems America, Inc.
MOS · Coil, Magnetic Resonance, Specialty · 63d
Cleared Oct 07, 1999
CET PROSTATE APPLICATOR SET, PART NUMBER 089.066
K990990 · Nucletron Corp.
JAQ · System, Applicator, Radionuclide, Remote-controlled · 197d
Cleared Oct 07, 1999
BEACON-P, MODEL 211059
K992335 · Philips Medical Systems (Cleveland), Inc.
KPS · System, Tomography, Computed, Emission · 86d
Cleared Oct 07, 1999
EMORY CARDIAC TOOLBOX* 2.0 EXECUTING ON NUCLEAR MEDICINE COMPUTERS
K992450 · Emory University
KPS · System, Tomography, Computed, Emission · 77d
Cleared Oct 07, 1999
CARDIOVASCULAR WORKSTATION, MODEL CWS 5000/CWS 3000
K992575 · Infimed, Inc.
LLZ · System, Image Processing, Radiological · 66d
Cleared Oct 07, 1999
TOSHIBA RTP9211J-G11, J-ADVANCED IMAGE INTENSIFIER (I.I.)
K993038 · Toshiba America Medical Systems, In.C
JAA · System, X-ray, Fluoroscopic, Image-intensified · 27d
Cleared Oct 05, 1999
PREFERENCE TREATMENT SYSTEM
K983793 · Northwest Medical Physics Equipment, Inc.
LNH · System, Nuclear Magnetic Resonance Imaging · 343d
Cleared Oct 04, 1999
INDIGO PROSTATE SEEDING NEEDLE CARTRIDGE SYSTEM
K992262 · Indigo Medical, Inc.
KXK · Source, Brachytherapy, Radionuclide · 90d
Cleared Oct 01, 1999
AUTOSPECT PLUS WITH INSTILL MOTION CORRECTION
K992317 · Adac Laboratories
KPS · System, Tomography, Computed, Emission · 84d
Cleared Oct 01, 1999
OPTION FOR THE QDR BONE DENSITOMETER, MODELS QDR4500, QDR2000, QDR1500, QDR4000, QDR1000, QDR1000W
K992775 · Hologic, Inc.
KGI · Densitometer, Bone · 44d
Cleared Oct 01, 1999
SILHOUETTE FC
K993090 · Ge Medical Systems, Inc.
KPR · System, X-ray, Stationary · 15d
Cleared Sep 29, 1999
ITR2000: INTERNET TELERADIOLOGY, MODEL RELEASE 1.0
K992352 · Inteleradiology, Inc.
LMD · System, Digital Image Communications, Radiological · 77d
Cleared Sep 29, 1999
DIAGNOSTIC ULTRASOUND, MODEL 1.0
K992378 · Volumetrics Medical Imaging, Inc.
IYO · System, Imaging, Pulsed Echo, Ultrasonic · 75d
Cleared Sep 28, 1999
ORTHOPANTOMOGRAPH OP100D
K992385 · Instrumentarium Corp.
MUH · System, X-ray, Extraoral Source, Digital · 74d
Cleared Sep 23, 1999
ACCUIMAGE, ACCUVIEW DIAGNOSTIC IMAGING, WORKSTATION W/ACCUSCORE, ACCUANALYZE, ACCUSCOPE, ACCUSHADE, ACCUVRT, AND ACCUMIP
K990241 · Accuimage Diagnostics Corp.
LLZ · System, Image Processing, Radiological · 241d
Cleared Sep 23, 1999
PHOTON RADIOSURGERY SYSTEM (PRS)
K992577 · Photoelectron Corporation
JAD · System, Therapeutic, X-ray · 52d
Cleared Sep 22, 1999
SAMSUNG RAYPAX DISPLAY WORKSTATION
K992306 · Samsung Sds Co., Ltd.
LLZ · System, Image Processing, Radiological · 75d
Cleared Sep 22, 1999
GE DIASONICS GATEWAY AND GATEWAY FX
K993069 · General Electric Co.
IYO · System, Imaging, Pulsed Echo, Ultrasonic · 9d
Cleared Sep 21, 1999
RAYCAST IMMOBILIZATION SYSTEMS HARDWARE AND THERMOPLASTIC MATERIALS
K991319 · Orfit Industries
IYE · Accelerator, Linear, Medical · 155d

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All categories 12832 LLZ System, Image Processing, Radiological 2037 IYN System, Imaging, Pulsed Doppler, Ultrasonic 1128 LNH System, Nuclear Magnetic Resonance Imaging 998 JAK System, X-ray, Tomography, Computed 749 IYO System, Imaging, Pulsed Echo, Ultrasonic 686 IYE Accelerator, Linear, Medical 586 MOS Coil, Magnetic Resonance, Specialty 458 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 314 KPR System, X-ray, Stationary 296 MUJ System, Planning, Radiation Therapy Treatment 236 MUH System, X-ray, Extraoral Source, Digital 193