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
12659 Radiology devices
6976–7000 of 12659
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
Cleared Feb 22, 2008
XVIEWNET
K080290 · American Radiologist Network, Inc.
LLZ · System, Image Processing, Radiological · 18d
Cleared Feb 22, 2008
IMAGEGRID
K080333 · Candelis, Inc.
LLZ · System, Image Processing, Radiological · 15d
Cleared Feb 21, 2008
I-DIXEL
K073704 · J. Morita USA, Inc.
LLZ · System, Image Processing, Radiological · 52d
Cleared Feb 21, 2008
CLEARSCAN
K080119 · Esi, Inc.
ITX · Transducer, Ultrasonic, Diagnostic · 35d
Cleared Feb 21, 2008
PRIMEVUE 21 3MP COLOR DISPLAY, MODEL AC-QX21-A9300
K080320 · Nds Surgical Imaging
LLZ · System, Image Processing, Radiological · 15d
Cleared Feb 21, 2008
INSTARAD
K080334 · Medsphere Technologies Pvt , Ltd.
LLZ · System, Image Processing, Radiological · 14d
Cleared Feb 20, 2008
VITREA 4DCT
K072821 · Vital Images, Inc.
LLZ · System, Image Processing, Radiological · 141d
Cleared Feb 14, 2008
CORONIS FUSION 6MP DL, MODEL: MDCC 6130 DL
K073007 · Barcoview, Medical Imaging Systems
LLZ · System, Image Processing, Radiological · 113d

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All categories 12659 LLZ System, Image Processing, Radiological 2008 IYN System, Imaging, Pulsed Doppler, Ultrasonic 1116 LNH System, Nuclear Magnetic Resonance Imaging 991 JAK System, X-ray, Tomography, Computed 744 IYO System, Imaging, Pulsed Echo, Ultrasonic 673 IYE Accelerator, Linear, Medical 572 MOS Coil, Magnetic Resonance, Specialty 448 MQB Solid State X-ray Imager (flat Panel/digital Imager) 407 KPS System, Tomography, Computed, Emission 384 ITX Transducer, Ultrasonic, Diagnostic 341 QIH Automated Radiological Image Processing Software 320 OWB Interventional Fluoroscopic X-ray System 310 KPR System, X-ray, Stationary 287 MUJ System, Planning, Radiation Therapy Treatment 228 JAA System, X-ray, Fluoroscopic, Image-intensified 190