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
7026–7050 of 12692
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
Cleared Feb 14, 2008
CMRTOOLS AND PLUG-INS VENTRICULAR TOOLS & THALASSAEMIA TOOLS
K073194 · Cardiovascular Imaging Solutions , Ltd.
LLZ · System, Image Processing, Radiological · 93d
Cleared Feb 14, 2008
TERASON ECHO T/3000 ULTRASOUND SYSTEM WITH STRESS ECHO
K080234 · Teratech Corp.
IYO · System, Imaging, Pulsed Echo, Ultrasonic · 15d
Cleared Feb 11, 2008
15M MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR MDL2123A (MS51I2)
K071794 · Totoku Electric Co., Ltd.
LLZ · System, Image Processing, Radiological · 224d
Cleared Feb 11, 2008
ARTIS ZEE AND ZEEGO
K073290 · Siemens Medical Solutions USA, Inc.
IZI · System, X-ray, Angiographic · 82d
Cleared Feb 11, 2008
KODAK 9000, KODAK 9000 3D
K073435 · Trophy
MUH · System, X-ray, Extraoral Source, Digital · 67d
Cleared Feb 11, 2008
OASIS RAPID BREAST COIL, MODEL MR-IBC-120 AND OASIS RAPID NV COIL, MODEL MR-NVC-120
K080062 · Hitachi Medical Systems America, Inc.
MOS · Coil, Magnetic Resonance, Specialty · 33d
Cleared Feb 08, 2008
APLIO ARTIDA, MODEL SSH-880CV DIAGNOSTIC ULTRASOUND SYSTEM
K080160 · Toshiba America Medical Systems, In.C
IYN · System, Imaging, Pulsed Doppler, Ultrasonic · 16d
Cleared Feb 07, 2008
SYNGO DUAL ENERGY WITH EXTENDED FUNCTIONALLY
K073003 · Siemens Medi Cal Solutions, Inc.
JAK · System, X-ray, Tomography, Computed · 106d
Cleared Feb 06, 2008
FUJIFILM UNITY SPEEDSUITE, MODEL CR-IR 371
K073650 · Fujifilm Medical Systems U.S.A, Inc.
KPR · System, X-ray, Stationary · 42d
Cleared Feb 06, 2008
MSK EXTREME MR SCANNER, MODEL AA5000
K080048 · Oni Medical Systems, Inc.
LNH · System, Nuclear Magnetic Resonance Imaging · 29d
Cleared Feb 01, 2008
MSTAR MPD4500
K073457 · Xinaomdt Technology Co., Ltd.
LNH · System, Nuclear Magnetic Resonance Imaging · 53d
Cleared Jan 31, 2008
VENTRI 1.1
K080124 · Ge Medical Systems F.I. Haifa
KPS · System, Tomography, Computed, Emission · 14d
Cleared Jan 25, 2008
KODAK POINT OF CARE CR 120, KODAK POINT OF CARE CR 140, KODAK POINT OF CARE CR 260
K073670 · Orex Computed Radiography, Ltd.
MQB · Solid State X-ray Imager (flat Panel/digital Imager) · 29d
Cleared Jan 24, 2008
3VISEON/SURGERY
K072653 · 3Mensio Medical Imaging BV
LLZ · System, Image Processing, Radiological · 126d
Cleared Jan 23, 2008
STEREOTACTIC TARGET POSITIONER, TARGET POSITIONER FOR LEKSELL HEADRING, STEREOTACTIC COUNTERWEIGHT
K073018 · Brainlab AG
IYE · Accelerator, Linear, Medical · 90d
Cleared Jan 23, 2008
DOSE VERIFICATION SYSTEM PATIENT DOSIMETRY SYSTEM
K080004 · Sicel Technologies, Inc.
NZT · Dosimeter, Ionizing Radiation, Implanted · 21d
Cleared Jan 23, 2008
VASCUVIEW ULTRASOUND SYSTEM
K080049 · Escalon Medical Corp.
IYO · System, Imaging, Pulsed Echo, Ultrasonic · 15d

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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