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

15507
Total
15488
Cleared
146d
Avg (2y)
1976
Since
4659 Radiology devices
3801–3825 of 4659
Cleared Dec 23, 2009
RADIONUCLIDE BRACHYTHERAPY SOURCE
K093663 · C.R. Bard, Inc.
KXK · Source, Brachytherapy, Radionuclide · 28d
Cleared Oct 09, 2009
PHILIPS COMPREHENSIVE CARDIAC ANALYSIS (CCA) - PLAQUE ASSESSMENT TOOL
K092747 · Philips Medical Systems (Cleveland), Inc.
JAK · System, X-ray, Tomography, Computed · 31d
Cleared Sep 18, 2009
160MLC OPTION
K092145 · Siemens Medical Solutions USA, Inc.
IYE · Accelerator, Linear, Medical · 65d
Cleared Jun 23, 2009
BRILLIANCE DUAL ENERGY OPTION
K090462 · Philips Medical Systems (Cleveland), Inc.
JAK · System, X-ray, Tomography, Computed · 120d
Cleared Jun 18, 2009
ARTIS ZEE / ZEEGOS WITH SW VC14
K090745 · Siemens Medical Solutions USA, Inc.
IZI · System, X-ray, Angiographic · 90d
Cleared May 27, 2009
PHILIPS MX 16 SLICE CT SYSTEM PHASE11, MODEL 9896 056 56511
K091195 · Philips Medical Systems (Cleveland), Inc.
JAK · System, X-ray, Tomography, Computed · 34d
Cleared May 20, 2009
SYNGO TRUED
K091373 · Siemens Medical Solutions USA, Inc.
LLZ · System, Image Processing, Radiological · 9d
Cleared May 18, 2009
SYNGOCIRCULATION DYNAMICPET, VERSION 1.0
K083327 · Siemens Medical Solutions USA, Inc.
LLZ · System, Image Processing, Radiological · 187d
Cleared May 15, 2009
SYNGO US WORKPLACE
K091286 · Siemens Medical Solutions USA, Inc.
LLZ · System, Image Processing, Radiological · 14d
Cleared May 08, 2009
SYNGO RT THERAPIST CONNECT
K090683 · Siemens Medical Solutions USA, Inc.
IYE · Accelerator, Linear, Medical · 53d
Cleared Apr 28, 2009
SYNGO BREVIS
K090038 · Siemens Medical Solutions USA, Inc.
LNH · System, Nuclear Magnetic Resonance Imaging · 112d
Cleared Apr 01, 2009
SYNGO DUAL ENERGY WITH EXTENDED FUNATIONALLY
K083524 · Siemens Medical Solutions USA, Inc.
JAK · System, X-ray, Tomography, Computed · 124d
Cleared Mar 31, 2009
AUTOSPECT
K090403 · Philips Medical Systems (Cleveland), Inc.
KPS · System, Tomography, Computed, Emission · 42d
Cleared Mar 31, 2009
ACUSON P50 ULTRASOUND SYSTEM
K083114 · Siemens Medical Solutions USA, Inc.
IYN · System, Imaging, Pulsed Doppler, Ultrasonic · 161d
Cleared Mar 23, 2009
BIOGRAPH 16 TRUE POINT SYSTEMS
K083852 · Siemens Medical Solutions USA, Inc.
KPS · System, Tomography, Computed, Emission · 89d
Cleared Feb 19, 2009
ACUSON X300 DIAGNOSTIC ULTRASOUND SYSTEM
K090276 · Siemens Medical Solutions USA, Inc.
DQO · Catheter, Intravascular, Diagnostic · 15d
Cleared Feb 19, 2009
PRESCISION OPTION
K082775 · Siemens Medical Solutions USA, Inc.
IYE · Accelerator, Linear, Medical · 150d
Cleared Jan 14, 2009
ARTERIAL HEALTH PACKAGE (AHP) SOFTWARE
K083149 · Siemens Medical Solutions USA, Inc.
LLZ · System, Image Processing, Radiological · 82d
Cleared Jan 13, 2009
SPECIALTY COILS FOR THE MAGNETOM ESSENZA
K083166 · Siemens Medical Solutions USA, Inc.
MOS · Coil, Magnetic Resonance, Specialty · 78d
Cleared Dec 17, 2008
PHILIPS MODEL MX 16 SLICE CT SYSTEM
K083498 · Philips Medical Systems (Cleveland), Inc.
JAK · System, X-ray, Tomography, Computed · 22d
Cleared Nov 21, 2008
SYMBIA, VERSION 4.0
K082506 · Siemens Medical Solutions USA, Inc.
KPS · System, Tomography, Computed, Emission · 84d
Cleared Nov 07, 2008
SYNGO MR B17
K082427 · Siemens Medical Solutions USA, Inc.
LNH · System, Nuclear Magnetic Resonance Imaging · 77d
Cleared Oct 10, 2008
SOMATOM FLASH DS
K082220 · Siemens Medical Solutions USA, Inc.
JAK · System, X-ray, Tomography, Computed · 65d
Cleared Oct 01, 2008
MAGNETOM C!
K082331 · Siemens Medical Solutions USA, Inc.
LNH · System, Nuclear Magnetic Resonance Imaging · 48d
Cleared Sep 26, 2008
GE LUNAR FRAX 10-YEAR FRACTURE RISK SOFTWARE OPTION
K082317 · General Electric Co.
KGI · Densitometer, Bone · 44d

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All categories 4659 LLZ System, Image Processing, Radiological 716 IYN System, Imaging, Pulsed Doppler, Ultrasonic 532 LNH System, Nuclear Magnetic Resonance Imaging 384 JAK System, X-ray, Tomography, Computed 339 QIH Automated Radiological Image Processing Software 296 OWB Interventional Fluoroscopic X-ray System 176 IYO System, Imaging, Pulsed Echo, Ultrasonic 168 IYE Accelerator, Linear, Medical 164 KPS System, Tomography, Computed, Emission 142 MQB Solid State X-ray Imager (flat Panel/digital Imager) 141 KPR System, X-ray, Stationary 102 MUJ System, Planning, Radiation Therapy Treatment 91 IZL System, X-ray, Mobile 89 QAS Radiological Computer-assisted Triage And Notification Software 85 MOS Coil, Magnetic Resonance, Specialty 75