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
12648 Radiology devices
6626–6650 of 12648
Cleared Mar 09, 2009
CLEARVUE PRONE BREAST TREATMENT TABLE
K090349 · Orbital Therapy, LLC
IYE · Accelerator, Linear, Medical · 26d
Cleared Mar 09, 2009
CARDIUS 3 X-ACT
K083649 · Digirad Corp.
KPS · System, Tomography, Computed, Emission · 90d
Cleared Mar 09, 2009
PRISM ACQUIRE (VERSION 1.5), PRISM PROCESS (VERSION 1.5), PRISM VIEW (VERSION 2.5)
K082964 · Prism Clinical Imaging, Inc.
LNH · System, Nuclear Magnetic Resonance Imaging · 157d
Cleared Mar 05, 2009
CSBP-001A BODY PERFUSION SYSTEM
K090504 · Toshibamedical Systems Corporation
JAK · System, X-ray, Tomography, Computed · 7d
Cleared Mar 04, 2009
BODYVIZ, MODEL 100
K090295 · Visual Medical Solutions, LLC
LLZ · System, Image Processing, Radiological · 27d
Cleared Mar 04, 2009
DATACOM DC PACS
K083182 · Datacom Technology Corp.
LLZ · System, Image Processing, Radiological · 127d
Cleared Mar 02, 2009
RADIONICS XKNIFE HDRT SYSTEM
K083414 · Integra Radionics, Inc.
MUJ · System, Planning, Radiation Therapy Treatment · 104d
Cleared Feb 27, 2009
SEDECAL X-PLUS LP PLUS DIGITAL DIAGNOSTIC X-RAY SYSTEMS
K090238 · Sedecal., Sa.
KPR · System, X-ray, Stationary · 25d
Cleared Feb 25, 2009
BONEVUE
K083691 · Micromri, Inc.
LLZ · System, Image Processing, Radiological · 75d
Cleared Feb 25, 2009
VISIX IMAGING
K082623 · Televere Systems
LLZ · System, Image Processing, Radiological · 169d
Cleared Feb 25, 2009
CONTEC POCKET FETAL DOPPLER
K082480 · Contec Medical System Co., Ltd.
KNG · Monitor, Ultrasonic, Fetal · 181d
Cleared Feb 24, 2009
RADSTAR FAMILY, MODELS: RADSTAR 4343 & VARIATIONS
K083645 · 5 Star Medical, Inc.
MQB · Solid State X-ray Imager (flat Panel/digital Imager) · 77d
Cleared Feb 24, 2009
NEONATE HEAD AND BODY COILS
K083541 · Advanced Imaging Research, Inc.
MOS · Coil, Magnetic Resonance, Specialty · 88d
Cleared Feb 23, 2009
RESOLUTIONMD, RELEASE 2.1
K082693 · Calgary Scientific, Inc.
LLZ · System, Image Processing, Radiological · 161d
Cleared Feb 20, 2009
ACUSON S2000 DIAGNOSTIC ULTRASOUND SYSTEM
K090334 · Siemens Medi Cal Solutions, Inc.
IYN · System, Imaging, Pulsed Doppler, Ultrasonic · 10d
Cleared Feb 19, 2009
ATOMLAB 400 AND ATOMLAB 500 DOSE CALIBRATORS, MODELS 086-330, -331, -332, -335 AND -336
K090296 · Biodex Medical Systems, Inc.
KPT · Calibrator, Dose, Radionuclide · 13d
Cleared Feb 19, 2009
ACUSON X300 DIAGNOSTIC ULTRASOUND SYSTEM
K090276 · Siemens Medical Solutions USA, Inc.
DQO · Catheter, Intravascular, Diagnostic · 15d
Cleared Feb 19, 2009
NEUROSCAPE
K083491 · Olea Medical
LLZ · System, Image Processing, Radiological · 86d
Cleared Feb 19, 2009
PRESCISION OPTION
K082775 · Siemens Medical Solutions USA, Inc.
IYE · Accelerator, Linear, Medical · 150d
Cleared Feb 17, 2009
THE IC-PRO SYSTEM, MODEL VERSION 3.2
K083745 · Paieon, Inc.
IZI · System, X-ray, Angiographic · 63d
Cleared Feb 17, 2009
ECHELON C MRI SYSTEM
K083533 · Hitachi Medical Systems America, Inc.
LNH · System, Nuclear Magnetic Resonance Imaging · 81d
Cleared Feb 17, 2009
RAD SOURCE X-RAY BLOOD IRRADIATOR, MODEL RS-3400
K082921 · Rad Source Technologies, Inc.
MOT · Irradiator, Blood To Prevent Graft Versus Host Disease · 139d
Cleared Feb 13, 2009
MAMMODIAGNOST VU
K083740 · Philips Medical Systems Nederland B.V.
LLZ · System, Image Processing, Radiological · 59d
Cleared Feb 13, 2009
DRAD30003/RADREX-I
K083503 · Toshiba America Medical Systems, In.C
KPR · System, X-ray, Stationary · 79d
Cleared Feb 11, 2009
COLON VIEW, MODEL CSCV-001A
K090220 · Toshibamedical Systems Corporation
JAK · System, X-ray, Tomography, Computed · 13d

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All categories 12648 LLZ System, Image Processing, Radiological 2003 IYN System, Imaging, Pulsed Doppler, Ultrasonic 1116 LNH System, Nuclear Magnetic Resonance Imaging 991 JAK System, X-ray, Tomography, Computed 743 IYO System, Imaging, Pulsed Echo, Ultrasonic 673 IYE Accelerator, Linear, Medical 571 MOS Coil, Magnetic Resonance, Specialty 447 MQB Solid State X-ray Imager (flat Panel/digital Imager) 407 KPS System, Tomography, Computed, Emission 384 ITX Transducer, Ultrasonic, Diagnostic 341 QIH Automated Radiological Image Processing Software 320 OWB Interventional Fluoroscopic X-ray System 309 KPR System, X-ray, Stationary 287 MUJ System, Planning, Radiation Therapy Treatment 228 JAA System, X-ray, Fluoroscopic, Image-intensified 190