FDA 510(k) Radiology Devices
About Radiology Devices
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
15452
Total
15433
Cleared
107d
Avg days
1976
Since
1589 Radiology devices
Cleared
Dec 21, 2022
8MP Color LCD Monitor CL-R813
PGY
Display, Diagnostic Radiology
90d
Cleared
Dec 07, 2022
Cios Select (VA21) Flat Panel
OWB
Interventional Fluoroscopic X-ray System
28d
Cleared
Dec 06, 2022
Cios Select (VA21) Image Intensifier
OWB
Interventional Fluoroscopic X-ray System
27d
Cleared
Dec 06, 2022
R2 Studio Q/RCT820
OAS
X-ray, Tomography, Computed, Dental
134d
Cleared
Dec 05, 2022
BriefCase
QFM
Radiological Computer-assisted Prioritization Software For Lesions
90d
Cleared
Dec 01, 2022
ProBeam 360° Proton Therapy System
LHN
System, Radiation Therapy, Charged-particle, Medical
163d
Cleared
Nov 22, 2022
Vision 2, EVARVision, TrackVision 2, HeartVision 2
LLZ
System, Image Processing, Radiological
47d
Cleared
Nov 22, 2022
DynamicIQ
KPS
System, Tomography, Computed, Emission
60d
Cleared
Nov 22, 2022
VitroPRO
ITX
Transducer, Ultrasonic, Diagnostic
133d
Cleared
Nov 21, 2022
SM-V
IZL
System, X-ray, Mobile
55d
Cleared
Nov 18, 2022
EXPD 86P, EXPD 86PG, EXPD 129P, EXPD 129PG
MQB
Solid State X-ray Imager (flat Panel/digital Imager)
46d
Cleared
Nov 18, 2022
BriefCase
QAS
Radiological Computer-assisted Triage And Notification Software
196d
Cleared
Nov 17, 2022
SKR 3000
MQB
Solid State X-ray Imager (flat Panel/digital Imager)
24d
Cleared
Nov 14, 2022
uPMR 790
OUO
Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance
84d
Cleared
Nov 14, 2022
Syngo Dynamics (Version VA40F)
QIH
Automated Radiological Image Processing Software
95d
Cleared
Nov 10, 2022
Synapse 3D Base Tools v6.6
LLZ
System, Image Processing, Radiological
154d
Cleared
Oct 31, 2022
CW60N
PGY
Display, Diagnostic Radiology
53d
Cleared
Oct 31, 2022
CL24N
PGY
Display, Diagnostic Radiology
53d
Cleared
Oct 27, 2022
uMR Omega with uWS-MR-MRS
LNH
System, Nuclear Magnetic Resonance Imaging
265d
Cleared
Oct 26, 2022
EzRay Air 2 Wall (Model: VEX-S350W)
EHD
Unit, X-ray, Extraoral With Timer
26d
Cleared
Oct 25, 2022
Vantage Fortian/Orian 1.5T, MRT-1550, V8.0 with AiCE Reconstruction Processing Unit for MR
LNH
System, Nuclear Magnetic Resonance Imaging
28d
Cleared
Oct 20, 2022
Mercu 1717V
MQB
Solid State X-ray Imager (flat Panel/digital Imager)
27d
Cleared
Oct 20, 2022
AI-Rad Companion (Musculoskeletal)
JAK
System, X-ray, Tomography, Computed
77d
Cleared
Oct 17, 2022
Digital Radiography CXDI-Pro, Digital Radiography D1
MQB
Solid State X-ray Imager (flat Panel/digital Imager)
26d
Cleared
Oct 14, 2022
syngo.via View&GO
LLZ
System, Image Processing, Radiological
144d
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