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
12520 Radiology devices
Cleared
Aug 04, 2015
CareView 1500Cw X-ray Flat Panel Detectors
MQB
Solid State X-ray Imager (flat Panel/digital Imager)
120d
Cleared
Aug 03, 2015
QuantorView
LLZ
System, Image Processing, Radiological
41d
Cleared
Jul 31, 2015
SyncVision System
OWB
Interventional Fluoroscopic X-ray System
18d
Cleared
Jul 31, 2015
Arthrex OrthoVis Preoperative Plan
LLZ
System, Image Processing, Radiological
51d
Cleared
Jul 31, 2015
PSPIX 2 scanner, Imaging Plate Size 0 for PSPIX2 scanner, Imaging Plate Size 1 for PSPIX2 scanner, Imaging Plate Size 2 for PSPIX2 scanner, Imaging Plate Size 3 for PSPIX2 scanner
MUH
System, X-ray, Extraoral Source, Digital
102d
Cleared
Jul 30, 2015
5MP Monochrome LCD Monitor, RadiForce GX540
PGY
Display, Diagnostic Radiology
21d
Cleared
Jul 29, 2015
Atlas SPEEDER Header/Neck
MOS
Coil, Magnetic Resonance, Specialty
23d
Cleared
Jul 29, 2015
3D/5D Viewer
LLZ
System, Image Processing, Radiological
27d
Cleared
Jul 29, 2015
ECHELON Oval V 5.0 MRI System
LNH
System, Nuclear Magnetic Resonance Imaging
104d
Cleared
Jul 29, 2015
GenIQ
LLZ
System, Image Processing, Radiological
246d
Cleared
Jul 28, 2015
3MP (X213C3P0E, X213G3P0E) and 2MP (X213C2P0E, X213G2P0E) LCD Display
LLZ
System, Image Processing, Radiological
21d
Cleared
Jul 28, 2015
Proton Immobilization Solution
IYE
Accelerator, Linear, Medical
83d
Cleared
Jul 28, 2015
QBit Series Diagnostic Ultrasound System
IYN
System, Imaging, Pulsed Doppler, Ultrasonic
118d
Cleared
Jul 24, 2015
EPX-Series Mobile X-ray System
IZL
System, X-ray, Mobile
95d
Cleared
Jul 23, 2015
E-CUBE 15 Diagnostic Ultrasound System
IYN
System, Imaging, Pulsed Doppler, Ultrasonic
121d
Cleared
Jul 23, 2015
iuStar300 Medical Ultrasound Diagnostic System
IYN
System, Imaging, Pulsed Doppler, Ultrasonic
393d
Cleared
Jul 19, 2015
EzSensor Soft, EzSensor Soft i, EzSensor Bio, and EzSensor Bio i
MUH
System, X-ray, Extraoral Source, Digital
25d
Cleared
Jul 17, 2015
Hi-Light Diagnostic Ultrasound Systems
IYO
System, Imaging, Pulsed Echo, Ultrasonic
23d
Cleared
Jul 17, 2015
GUA60A, GU60A-65
KPR
System, X-ray, Stationary
25d
Cleared
Jul 17, 2015
Coronis Uniti
PGY
Display, Diagnostic Radiology
43d
Cleared
Jul 17, 2015
Biograph mCT and mCT Flow PET/CT Scanners
KPS
System, Tomography, Computed, Emission
45d
Cleared
Jul 17, 2015
3D Interstitial Ring Applicator Set 60, 3D Interstitial Ring Applicator Set 90, Ring Applicator Set 45, Ring Applicator Set 60, Ring Applicator Set 90
JAQ
System, Applicator, Radionuclide, Remote-controlled
109d
Cleared
Jul 17, 2015
UltraLinq
LLZ
System, Image Processing, Radiological
255d
Cleared
Jul 13, 2015
Vitrea Software Toshiba Package, VSTP-001A
LLZ
System, Image Processing, Radiological
81d
Cleared
Jul 13, 2015
Aura DR 43C-AG flat panel detector
MQB
Solid State X-ray Imager (flat Panel/digital Imager)
88d
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