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
12535 Radiology devices
4876–4900 of 12535
Cleared Oct 16, 2014
Intra-operative Ultrasound Transducer, PROSOUND ALPHA 7 Diagnostic Ultrasound System, ARIETTA 70 Diagnostic Ultrasound System
K142618 · Hitachi Aloka Medical America, Inc.
ITX · Transducer, Ultrasonic, Diagnostic · 30d
Cleared Oct 16, 2014
DX-D IMAGING PACKAGE
K142184 · Agfa Healthcare N.V.
MQB · Solid State X-ray Imager (flat Panel/digital Imager) · 69d
Cleared Oct 16, 2014
SYNGO CT SINGLE SOURCE DUAL ENERGY
K133677 · Siemens Medical Solutions USA, Inc.
JAK · System, X-ray, Tomography, Computed · 321d
Cleared Oct 10, 2014
Acuson SC2000 Diagnostic Ultrasound System
K142628 · Siemens Medi Cal Solutions, Inc.
IYN · System, Imaging, Pulsed Doppler, Ultrasonic · 24d
Cleared Oct 10, 2014
Vivid S60 Diagnostic Ultrasound System, Vivid S70 Diagnostic Ultrasound System
K142323 · Ge Medical Systems Israel , Ltd.
IYN · System, Imaging, Pulsed Doppler, Ultrasonic · 51d
Cleared Oct 10, 2014
LOGIQ E9 DIAGNOSTIC ULTRASOUND SYSTEM
K142160 · Ge Healthcare
IYN · System, Imaging, Pulsed Doppler, Ultrasonic · 65d
Cleared Oct 10, 2014
QUANTRA
K142037 · Hologic, Inc.
LLZ · System, Image Processing, Radiological · 74d
Cleared Oct 08, 2014
MAGNETOM Combi Suite Neurosurgery for the MAGNETOM Aera, MAGNETOM Combi Suite Neurosurgery for the MAGNETOM Skyra
K142515 · Siemens Medical Solutions USA, Inc.
LNH · System, Nuclear Magnetic Resonance Imaging · 30d
Cleared Oct 08, 2014
CLARITY
K141855 · Elekta , Ltd.
IYE · Accelerator, Linear, Medical · 91d
Cleared Oct 03, 2014
24.1 inch (61.1 cm) Color LCD Monitor CCL244 (CL24244)
K142540 · Jvckenwood Corporation
PGY · Display, Diagnostic Radiology · 24d
Cleared Oct 03, 2014
21.5 inch (54.5 cm) Color LCD Monitor CCL220 (CL22220)
K142536 · Jvckenwood Corporation
PGY · Display, Diagnostic Radiology · 24d
Cleared Oct 03, 2014
UGEO PT60A Diagnostic Ultrasound System
K142466 · Samsung Medison Co., Ltd.
IYN · System, Imaging, Pulsed Doppler, Ultrasonic · 31d
Cleared Oct 03, 2014
FDR D-EVO FLAT PANEL DETECTOR SYSTEM
K141765 · Fujifilm Medical Systems U.S.A, Inc.
MQB · Solid State X-ray Imager (flat Panel/digital Imager) · 94d
Cleared Oct 03, 2014
FUSION DIGITAL DIAGNOSTIC X-RAY UPGRADE KIT
K141743 · Radiology Solutions, LLC
MQB · Solid State X-ray Imager (flat Panel/digital Imager) · 95d
Cleared Oct 02, 2014
Varian Verification System (VVS)
K142268 · Varian Medical Systems, Inc.
IYE · Accelerator, Linear, Medical · 48d
Cleared Sep 29, 2014
IMACOR ZURA EVO IMAGING SYSTEM
K142054 · Imacor, Inc.
IYO · System, Imaging, Pulsed Echo, Ultrasonic · 62d
Cleared Sep 26, 2014
DISCOVERY MR750 3.0T ,DISCOVERY MR450 1.5T, DISCOVERY MR750 3.0T,OPTIMA MR450W 1.5T
K142085 · Ge Medical Systems, LLC
LNH · System, Nuclear Magnetic Resonance Imaging · 57d
Cleared Sep 26, 2014
PERFRACTION
K141800 · Sun Nuclear Corporation
IYE · Accelerator, Linear, Medical · 85d
Cleared Sep 26, 2014
UNIVERSAL SEGMENTED CYLINDER APPLICATOR SET AND UNIVERSAL STUMP APPLICATOR SET
K141490 · Varian Medical Systems, Inc.
JAQ · System, Applicator, Radionuclide, Remote-controlled · 113d
Cleared Sep 26, 2014
AERODR SYSTEM 2
K141271 · Konica Minolta, Inc.
MQB · Solid State X-ray Imager (flat Panel/digital Imager) · 134d
Cleared Sep 26, 2014
OPERA SWING
K140380 · General Medical Merate S.P.A
JAA · System, X-ray, Fluoroscopic, Image-intensified · 224d
Cleared Sep 25, 2014
Optima XR200amx, Optima XR220amx
K142383 · Ge Medical Systems, LLC
IZL · System, X-ray, Mobile · 30d
Cleared Sep 25, 2014
PHILIPS CT DYNAMIC MYOCARDIAL PERFUSION (DMP) APPLICATION
K133603 · Philips Medical Systems
JAK · System, X-ray, Tomography, Computed · 304d
Cleared Sep 19, 2014
CLEAR GUIDE ONE
K141806 · Clear Guide Medical
IYO · System, Imaging, Pulsed Echo, Ultrasonic · 78d
Cleared Sep 19, 2014
SURGIMAP
K141669 · Nemaris, Inc.
LLZ · System, Image Processing, Radiological · 88d

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All categories 12535 LLZ System, Image Processing, Radiological 1983 IYN System, Imaging, Pulsed Doppler, Ultrasonic 1112 LNH System, Nuclear Magnetic Resonance Imaging 982 JAK System, X-ray, Tomography, Computed 739 IYO System, Imaging, Pulsed Echo, Ultrasonic 666 IYE Accelerator, Linear, Medical 559 MOS Coil, Magnetic Resonance, Specialty 443 MQB Solid State X-ray Imager (flat Panel/digital Imager) 405 KPS System, Tomography, Computed, Emission 381 ITX Transducer, Ultrasonic, Diagnostic 336 QIH Automated Radiological Image Processing Software 320 OWB Interventional Fluoroscopic X-ray System 307 KPR System, X-ray, Stationary 284 MUJ System, Planning, Radiation Therapy Treatment 224 JAA System, X-ray, Fluoroscopic, Image-intensified 190