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
12621 Radiology devices
6176–6200 of 12621
Cleared Apr 07, 2011
4D SONO-SCAN 1.0
K110595 · Tomtec Imaging Systems GmbH
LLZ · System, Image Processing, Radiological · 36d
Cleared Apr 07, 2011
SYNAPSE 3D LIVER ANALYSIS
K110186 · Fujifilm Medical System U.S.A., Inc.
LLZ · System, Image Processing, Radiological · 76d
Cleared Apr 06, 2011
SYNGO MBF
K110494 · Siemens Medical Solutions USA, Inc.
LLZ · System, Image Processing, Radiological · 43d
Cleared Apr 06, 2011
TEMPOROMANIBULAR COIL 15
K110373 · Esaote, S.P.A.
MOS · Coil, Magnetic Resonance, Specialty · 57d
Cleared Apr 06, 2011
NEWTOM 5G / NEWTOM 5G VERSION FP
K110260 · Qr S.R.L.
OAS · X-ray, Tomography, Computed, Dental · 68d
Cleared Apr 01, 2011
1.5 GE 6-CHANNEL PHASED ARRAY FLEX COIL, 3.0 GE 6-CHANNEL PHASED ARRAY FLEX COIL
K110610 · Ge Medical Systems, LLC
MOS · Coil, Magnetic Resonance, Specialty · 29d
Cleared Mar 29, 2011
MC 1504G-16R, 1.5T, 16-CHANNEL, MC 3004G-16R, 3.0T, 16-CHANNEL HEAD COIL
K110591 · Mr Instruments, Inc.
MOS · Coil, Magnetic Resonance, Specialty · 27d
Cleared Mar 29, 2011
WIRELESS/WIRED FDR D-EVO FLAT PANEL DETECTOR
K103596 · Fujifilm Medical Systems U.S.A, Inc.
MQB · Solid State X-ray Imager (flat Panel/digital Imager) · 111d
Cleared Mar 29, 2011
DIGITAL RADIOGRAPHY
K103591 · Canon Inc. -Medical Equipment Group
MQB · Solid State X-ray Imager (flat Panel/digital Imager) · 112d
Cleared Mar 29, 2011
ZEN-7000, FLUOROSCOPIC X-RAY SYSTEM
K103425 · Genoray America, Inc.
OWB · Interventional Fluoroscopic X-ray System · 127d
Cleared Mar 25, 2011
COMPUTED TOMOGRAPHY X-RAY SYSTEM
K102196 · VATECH Co., Ltd.
OAS · X-ray, Tomography, Computed, Dental · 239d
Cleared Mar 24, 2011
CLEARCANVAS RIS / PACS
K110332 · Clearcanvas, Inc.
LLZ · System, Image Processing, Radiological · 49d
Cleared Mar 22, 2011
ACHIEVA R4 1.5T AND ACHIEVA R4 3.0T
K110151 · Philips Health Care
LNH · System, Nuclear Magnetic Resonance Imaging · 63d
Cleared Mar 22, 2011
ORTHOPHOS XG 3D / CEPH
K103711 · Sirona Dental Systems GmbH
OAS · X-ray, Tomography, Computed, Dental · 92d
Cleared Mar 22, 2011
IDEAL IQ SOFTWARE OPTION
K103411 · GE Medical Systems
LNH · System, Nuclear Magnetic Resonance Imaging · 120d
Cleared Mar 18, 2011
SENTINELLA 102
K110601 · General Equipment For Medical Imaging, S.A.
IYX · Camera, Scintillation (gamma) · 16d
Cleared Mar 18, 2011
PROSOUND C3 / C3 CV ULTRASOUND SYSTEMS
K110482 · Teratech Corp.
IYN · System, Imaging, Pulsed Doppler, Ultrasonic · 28d
Cleared Mar 18, 2011
INTRA SKAN DC
K103579 · Skanray Technologies
EHD · Unit, X-ray, Extraoral With Timer · 102d
Cleared Mar 17, 2011
ENCOMPASS HF100- EAGLE PANORAMIC/CEPHALOMETRIC X-RAY
K110371 · Panoramic Corp.
MUH · System, X-ray, Extraoral Source, Digital · 37d
Cleared Mar 17, 2011
PLANMECA PROMAX 3D MID
K103689 · Planmeca Oy
MUH · System, X-ray, Extraoral Source, Digital · 90d
Cleared Mar 17, 2011
AYCAN WORKSTATION OSIRIX PRO
K103546 · Aycan Digitalsysteme GmbH
LLZ · System, Image Processing, Radiological · 105d
Cleared Mar 17, 2011
NEXUS DRF DIGITAL X-RAY IMAGING SYSTEM
K103416 · Infimed, Inc.
OWB · Interventional Fluoroscopic X-ray System · 115d
Cleared Mar 16, 2011
DOPPLER MONITOR
K110347 · Cook Vascular, Inc.
DPW · Flowmeter, Blood, Cardiovascular · 37d
Cleared Mar 16, 2011
MODALIXX
K110108 · Ampronix, Inc.
LLZ · System, Image Processing, Radiological · 61d
Cleared Mar 16, 2011
SYNAPSE 3D LUNG AND ABDOMEN ANALYSIS
K103720 · Fujifilm Medical Systems U.S.A, Inc.
LLZ · System, Image Processing, Radiological · 85d

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All categories 12621 LLZ System, Image Processing, Radiological 2000 IYN System, Imaging, Pulsed Doppler, Ultrasonic 1115 LNH System, Nuclear Magnetic Resonance Imaging 990 JAK System, X-ray, Tomography, Computed 743 IYO System, Imaging, Pulsed Echo, Ultrasonic 671 IYE Accelerator, Linear, Medical 568 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 309 KPR System, X-ray, Stationary 287 MUJ System, Planning, Radiation Therapy Treatment 227 JAA System, X-ray, Fluoroscopic, Image-intensified 190