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
12747 Radiology devices
8051–8075 of 12747
Cleared Mar 25, 2005
LSO PET/CT HIREZ SERIES, MODELS 2I, 6I, 16I, 64I
K050509 · Cti Pet Systems, Inc.
KPS · System, Tomography, Computed, Emission · 24d
Cleared Mar 25, 2005
MODELS FAC-63 AND FAC-127 FOOT AND ANKLE COILS
K050514 · Mri Devices Corporation
MOS · Coil, Magnetic Resonance, Specialty · 24d
Cleared Mar 24, 2005
INTRACAVITARY MOULD APPLICATOR SET, MODEL 189.001
K041715 · Nucletron Corp.
JAQ · System, Applicator, Radionuclide, Remote-controlled · 274d
Cleared Mar 24, 2005
4D INTEGRATED TREATMENT CONSOLE
K050479 · Varian Medical Systems
IYE · Accelerator, Linear, Medical · 28d
Cleared Mar 23, 2005
MILLENNIUM MULTI-LEAF COLLIMATOR
K050442 · Varian Medical Systems
IYE · Accelerator, Linear, Medical · 29d
Cleared Mar 22, 2005
VOYAGER PERSONAL IMAGING DEVICE
K050551 · Ardent Sound, Inc.
IYO · System, Imaging, Pulsed Echo, Ultrasonic · 19d
Cleared Mar 18, 2005
STARSHIELD V3 RF TRNT
K050237 · Odin Medical Technologies , Ltd.
LNH · System, Nuclear Magnetic Resonance Imaging · 44d
Cleared Mar 18, 2005
550 TXT TREATMENT TABLE
K050422 · Siemens Medical Solutions USA, Inc.
JAI · Couch, Radiation Therapy, Powered · 28d
Cleared Mar 17, 2005
ARTHORALIX 8500, MODELS 110-0199G1, 110-0199G2, 110-0199G3, 110-0199G4
K050255 · Gendex Dental Systems
EHD · Unit, X-ray, Extraoral With Timer · 42d
Cleared Mar 17, 2005
IMAGENPRO
K050366 · Cardiovascular Imaging Technologies, LLC
KPS · System, Tomography, Computed, Emission · 31d
Cleared Mar 17, 2005
GE DISCOVERY VCT SYSTEM
K050559 · GE Medical Systems
KPS · System, Tomography, Computed, Emission · 14d
Cleared Mar 11, 2005
VISION
K042956 · Varian Medical Systems, Inc.
IYE · Accelerator, Linear, Medical · 135d
Cleared Mar 11, 2005
INNOVA 2100
K050489 · Ge Medical Systems, LLC
OWB · Interventional Fluoroscopic X-ray System · 14d
Cleared Mar 10, 2005
TSX-201A AQUILION LB CT SCANNER
K050458 · Toshiba America Medical Systems, In.C
JAK · System, X-ray, Tomography, Computed · 15d
Cleared Mar 01, 2005
SOMATOM EMOTION 16
K050297 · Siemens Medical Solution, Inc. USA
JAK · System, X-ray, Tomography, Computed · 22d
Cleared Feb 28, 2005
SHEATHES NEEDLE GUIDE, MODEL NG-SR-A-484-KIT (THERE WILL BE VARIOUS MODEL NUMBERS BASED ON TRANSDUCER AND COVER)
K043425 · Sheathing Technologies, Inc.
ITX · Transducer, Ultrasonic, Diagnostic · 77d
Cleared Feb 28, 2005
MAGNETOM TRIO A TIM SYSTEM
K050200 · Siemens Medical Solutions USA, Inc.
LNH · System, Nuclear Magnetic Resonance Imaging · 31d
Cleared Feb 28, 2005
IPACS PRISM-5.0
K050298 · Realtimeimage, Inc.
LLZ · System, Image Processing, Radiological · 21d
Cleared Feb 28, 2005
AIRIS ELITE RAPID BODY COIL
K050307 · Hitachi Medical Systems America, Inc.
MOS · Coil, Magnetic Resonance, Specialty · 20d
Cleared Feb 28, 2005
7350 ULTRASOUND IMAGING SYSTEM, MODEL 7350
K050326 · Esaote, S.P.A.
IYN · System, Imaging, Pulsed Doppler, Ultrasonic · 19d
Cleared Feb 25, 2005
MODIFICATION TO CRYOCARE CS SURGICAL SYSTEM
K050347 · Endocare, Inc.
GEH · Unit, Cryosurgical, Accessories · 14d
Cleared Feb 24, 2005
KODAK ORTHODONTIC IMAGING AND OMS IMAGING 8.0
K043104 · Practiceworks, Inc.
EHD · Unit, X-ray, Extraoral With Timer · 107d
Cleared Feb 24, 2005
SECTRA IDS5 WORKSTATION
K050196 · Sectra-Imtec AB
LLZ · System, Image Processing, Radiological · 28d
Cleared Feb 24, 2005
HRK-123 KNEE ARRAY COIL
K050299 · Mri Devices Corporation
MOS · Coil, Magnetic Resonance, Specialty · 17d
Cleared Feb 23, 2005
XARIO DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SSA-660A
K050380 · Toshiba America Medical Systems, In.C
IYN · System, Imaging, Pulsed Doppler, Ultrasonic · 8d

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All categories 12747 LLZ System, Image Processing, Radiological 2021 IYN System, Imaging, Pulsed Doppler, Ultrasonic 1121 LNH System, Nuclear Magnetic Resonance Imaging 995 JAK System, X-ray, Tomography, Computed 747 IYO System, Imaging, Pulsed Echo, Ultrasonic 680 IYE Accelerator, Linear, Medical 580 MOS Coil, Magnetic Resonance, Specialty 453 MQB Solid State X-ray Imager (flat Panel/digital Imager) 410 KPS System, Tomography, Computed, Emission 386 ITX Transducer, Ultrasonic, Diagnostic 345 QIH Automated Radiological Image Processing Software 320 OWB Interventional Fluoroscopic X-ray System 312 KPR System, X-ray, Stationary 289 MUJ System, Planning, Radiation Therapy Treatment 235 MUH System, X-ray, Extraoral Source, Digital 191