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
12692 Radiology devices
7001–7025 of 12692
Cleared Mar 26, 2008
BELLA
K073262 · Beekley Corp.
IZH · System, X-ray, Mammographic · 127d
Cleared Mar 21, 2008
ZIEHM VISION 2
K073346 · Ziehm Imaging, Inc.
JAK · System, X-ray, Tomography, Computed · 113d
Cleared Mar 21, 2008
M5 DIAGNOSTIC ULTRASOUND SYSTEM
K080640 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
IYN · System, Imaging, Pulsed Doppler, Ultrasonic · 15d
Cleared Mar 20, 2008
COLOR LCD MONITOR, MODEL RADIFORCE RX211
K080457 · Eizo Nanao Corporation
LLZ · System, Image Processing, Radiological · 29d
Cleared Mar 19, 2008
KANTERON DICOM STATION (KDS), MODEL 3.0
K073176 · Monica Veytia
LLZ · System, Image Processing, Radiological · 127d
Cleared Mar 19, 2008
TRAUMACAD VERSION 2.0
K073714 · Orthocrat, Ltd.
LLZ · System, Image Processing, Radiological · 79d
Cleared Mar 14, 2008
QUANTITATIVE NEUROQ 3.0
K072307 · Syntermed, Inc.
KPS · System, Tomography, Computed, Emission · 210d
Cleared Mar 14, 2008
RX DC X-RAY UNIT
K080076 · Cefla S.C.R.L.
EHD · Unit, X-ray, Extraoral With Timer · 63d
Cleared Mar 14, 2008
MODEL TSX-101A/H/I AQUILION 32/64 SP CT SYSTEM
K080211 · Toshiba America Medical Systems, In.C
JAK · System, X-ray, Tomography, Computed · 45d
Cleared Mar 13, 2008
ATLANTIS 018 PERIPHERAL IMAGING CATHETER
K073623 · Boston Scientific Corp
ITX · Transducer, Ultrasonic, Diagnostic · 78d
Cleared Mar 13, 2008
NEUSOFT SPIRAL CT SCANNER SYSTEM, MODEL NEUVIZ VERSION 2.0
K080540 · Neusoft Medical Systems Co., Ltd.
JAK · System, X-ray, Tomography, Computed · 15d
Cleared Mar 12, 2008
AMICAS VISION SERIES PACS, MODEL 5.5
K073526 · Amicas, Inc.
LLZ · System, Image Processing, Radiological · 86d
Cleared Mar 11, 2008
MODIFICATION TO VIEWMATE SYSTEM
K073709 · Ep Medsystems
IYN · System, Imaging, Pulsed Doppler, Ultrasonic · 71d
Cleared Mar 11, 2008
SONOTRAX ULTRASONIC FETAL AND VASCULAR POCKET DOPPLER, MODELS LITE, BASIC, PRO, II, II PRO AND VASCULAR
K080087 · Edan Instruments, Inc.
KNG · Monitor, Ultrasonic, Fetal · 60d
Cleared Mar 11, 2008
ATLANTIS PVIMAGING CATHETER, MODEL H749364560
K080272 · Boston Scientific Corp
ITX · Transducer, Ultrasonic, Diagnostic · 39d
Cleared Mar 10, 2008
OMNI-VUE SYSTEM
K073062 · Genesis Digital Imaging, Inc.
LLZ · System, Image Processing, Radiological · 132d
Cleared Mar 10, 2008
MRJ EXTENDED
K080098 · Paramed S.R.L.
LNH · System, Nuclear Magnetic Resonance Imaging · 56d
Cleared Mar 10, 2008
HFO SHOULDER COIL
K080120 · Philips Medical Systems MR Finland
MOS · Coil, Magnetic Resonance, Specialty · 53d
Cleared Mar 10, 2008
5 MEGAPIXEL MONOCHROME LCD MONITOR, MODEL RADIFORCE GS520
K080422 · Eizo Nanao Corporation
LLZ · System, Image Processing, Radiological · 24d
Cleared Mar 04, 2008
QPLAQUE MR
K073156 · Medis Medical Imaging Systems BV
LNH · System, Nuclear Magnetic Resonance Imaging · 117d
Cleared Feb 29, 2008
AXXENT ELECTRONIC BRACHYTHERAPY SYSTEM
K072683 · Xoft, Inc.
JAD · System, Therapeutic, X-ray · 161d
Cleared Feb 29, 2008
SYNGO IMAGING CCF VA10A
K073418 · Siemens AG Medical Solutions
LLZ · System, Image Processing, Radiological · 86d
Cleared Feb 29, 2008
ALOKA PROSOUND 6 DIAGNOSTIC ULTRASOUND SYSTEM
K080176 · Aloka Co., Ltd.
IYN · System, Imaging, Pulsed Doppler, Ultrasonic · 36d
Cleared Feb 26, 2008
CARDIQ EXPRESS VERSION 2.0
K073138 · GE Medical Systems
JAK · System, X-ray, Tomography, Computed · 111d
Cleared Feb 26, 2008
CARDIQ FUNCTION XPRESS
K073153 · GE Medical Systems SCS
JAK · System, X-ray, Tomography, Computed · 110d

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All categories 12692 LLZ System, Image Processing, Radiological 2013 IYN System, Imaging, Pulsed Doppler, Ultrasonic 1117 LNH System, Nuclear Magnetic Resonance Imaging 992 JAK System, X-ray, Tomography, Computed 746 IYO System, Imaging, Pulsed Echo, Ultrasonic 675 IYE Accelerator, Linear, Medical 572 MOS Coil, Magnetic Resonance, Specialty 452 MQB Solid State X-ray Imager (flat Panel/digital Imager) 408 KPS System, Tomography, Computed, Emission 384 ITX Transducer, Ultrasonic, Diagnostic 343 QIH Automated Radiological Image Processing Software 320 OWB Interventional Fluoroscopic X-ray System 311 KPR System, X-ray, Stationary 288 MUJ System, Planning, Radiation Therapy Treatment 230 JAA System, X-ray, Fluoroscopic, Image-intensified 190