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
12607 Radiology devices
6001–6025 of 12607
Cleared Oct 07, 2011
MULTIPLE
K112460 · Larson Medical Products, Inc.
IYE · Accelerator, Linear, Medical · 42d
Cleared Oct 07, 2011
TOMOTHERAPY TREATMENT SYSTEM
K112446 · Tomotherapy Incorporated
MUJ · System, Planning, Radiation Therapy Treatment · 44d
Cleared Oct 06, 2011
DRYVIEW CHROMA IMAGING SYSTEM
K111566 · Carestream Health, Inc.
LMC · Camera, Multi Format, Radiological · 122d
Cleared Oct 06, 2011
SENOGRAPH DS, SENOGRAPH ESSENSTIAL
K103485 · General Electric Company
MUE · Full Field Digital, System, X-ray, Mammographic · 314d
Cleared Oct 04, 2011
FLAATZ 560
K111583 · Drtech Corp.
MQB · Solid State X-ray Imager (flat Panel/digital Imager) · 119d
Cleared Oct 04, 2011
OEC(R) 9800, OEC(R) 9800 PLUS
K111551 · Ge Oec Medical Systems, Inc.
OWB · Interventional Fluoroscopic X-ray System · 123d
Cleared Oct 04, 2011
APLIO DIAGNOSTIC ULTRASOUND SYSTEM
K110870 · Toshiba America Medical Systems, In.C
IYN · System, Imaging, Pulsed Doppler, Ultrasonic · 189d
Cleared Sep 30, 2011
3DI INCLUDING CSCORE
K112530 · Shina Systems , Ltd.
LLZ · System, Image Processing, Radiological · 30d
Cleared Sep 30, 2011
HTS EXTREMITY COIL, HTS SURFACE COIL
K112293 · Time Medical Systems, Inc.
MOS · Coil, Magnetic Resonance, Specialty · 51d
Cleared Sep 30, 2011
IMAGELINK
K112096 · Computer Programs and Systems, Inc.
LLZ · System, Image Processing, Radiological · 70d
Cleared Sep 30, 2011
WIRED/ WIRELESS FDR D-EVO WITH X-RAY DETECTION FEATURE
K111865 · Fujifilm Medical System U.S.A., Inc.
MQB · Solid State X-ray Imager (flat Panel/digital Imager) · 92d
Cleared Sep 30, 2011
APEX
K111676 · Elekta Limited
IXI · Block, Beam-shaping, Radiation Therapy · 107d
Cleared Sep 30, 2011
SURGIMAP (TM) SPINE
K111019 · Nemaris, Inc.
LLZ · System, Image Processing, Radiological · 171d
Cleared Sep 30, 2011
DISCOVERY MR750W 3.0T
K103327 · Ge Healthcare Japan Corporation
LNH · System, Nuclear Magnetic Resonance Imaging · 322d
Cleared Sep 27, 2011
SONIX ULTRASOUND SCANNER
K112726 · Ultrasonix Medical Corporation
IYN · System, Imaging, Pulsed Doppler, Ultrasonic · 7d
Cleared Sep 27, 2011
LOGIQ P3
K112371 · Ge Healthcare
IYN · System, Imaging, Pulsed Doppler, Ultrasonic · 41d
Cleared Sep 27, 2011
HI VISION ASCENDUS DIAGNOSTIC ULTRASOUND SCANNER
K110673 · Hitachi Medical Systems America, Inc.
IYN · System, Imaging, Pulsed Doppler, Ultrasonic · 202d
Cleared Sep 26, 2011
SURGICASE ORTHOGNATHIC SOFTWARE WIZARD
K111641 · Materialise NV
LLZ · System, Image Processing, Radiological · 105d
Cleared Sep 26, 2011
21.3 INCH (54CM) MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR
K111496 · Totoku Electric Co., Ltd.
LLZ · System, Image Processing, Radiological · 118d
Cleared Sep 23, 2011
CSMC CARDIAC SUITE- NUCLEAR MEDICINE SOFTWARE
K112474 · Cedars-Sinai Medical Center
KPS · System, Tomography, Computed, Emission · 28d
Cleared Sep 23, 2011
VENUE 40
K112122 · Ge Healthcare
IYN · System, Imaging, Pulsed Doppler, Ultrasonic · 60d
Cleared Sep 23, 2011
LUMAGEM MOLECULAR BREAST IMAGING SYSTEM
K111791 · Gamma Medica-Ideas Incorporated
IYX · Camera, Scintillation (gamma) · 88d
Cleared Sep 23, 2011
CS 7600
K111649 · Carestream Health, Inc.
MUH · System, X-ray, Extraoral Source, Digital · 102d
Cleared Sep 23, 2011
PLANMED NUANCE EXCEL
K111361 · Planmeca USA, Inc.
MUE · Full Field Digital, System, X-ray, Mammographic · 130d
Cleared Sep 23, 2011
MAMMODIAGNOST DR
K110572 · Philips Medical Systems
MUE · Full Field Digital, System, X-ray, Mammographic · 206d

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All categories 12607 LLZ System, Image Processing, Radiological 1996 IYN System, Imaging, Pulsed Doppler, Ultrasonic 1115 LNH System, Nuclear Magnetic Resonance Imaging 987 JAK System, X-ray, Tomography, Computed 742 IYO System, Imaging, Pulsed Echo, Ultrasonic 671 IYE Accelerator, Linear, Medical 566 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 338 QIH Automated Radiological Image Processing Software 320 OWB Interventional Fluoroscopic X-ray System 307 KPR System, X-ray, Stationary 286 MUJ System, Planning, Radiation Therapy Treatment 227 JAA System, X-ray, Fluoroscopic, Image-intensified 190