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
1608 Radiology devices
Cleared
May 06, 2021
ImagePilot
LLZ
System, Image Processing, Radiological
115d
Cleared
Apr 30, 2021
HYPER AiR
KPS
System, Tomography, Computed, Emission
116d
Cleared
Apr 30, 2021
syngo. CT Extended Functionalities
JAK
System, X-ray, Tomography, Computed
133d
Cleared
Apr 28, 2021
1717FCC
MQB
Solid State X-ray Imager (flat Panel/digital Imager)
27d
Cleared
Apr 28, 2021
AMX Navigate
IZL
System, X-ray, Mobile
27d
Cleared
Apr 23, 2021
2MP Monochrome LCD Monitor MS-S200
PGY
Display, Diagnostic Radiology
77d
Cleared
Apr 23, 2021
PlutoX Digital Intraoral X-Ray Imaging System
MUH
System, X-ray, Extraoral Source, Digital
79d
Cleared
Apr 23, 2021
Cartesion Prime (PCD-1000A/3) V10.8
KPS
System, Tomography, Computed, Emission
164d
Cleared
Apr 20, 2021
Identify
IYE
Accelerator, Linear, Medical
29d
Cleared
Apr 19, 2021
AI Segmentation
MUJ
System, Planning, Radiation Therapy Treatment
145d
Cleared
Apr 14, 2021
CX30N (CX30PQX)
PGY
Display, Diagnostic Radiology
54d
Cleared
Apr 14, 2021
BriefCase, RIB Fractures Triage (RibFx)
QFM
Radiological Computer-assisted Prioritization Software For Lesions
196d
Cleared
Apr 12, 2021
Alphenix, INFX-8000C/B, INFX-8000C/S, V9.2
OWB
Interventional Fluoroscopic X-ray System
17d
Cleared
Apr 09, 2021
HYPER Focus
KPS
System, Tomography, Computed, Emission
57d
Cleared
Apr 09, 2021
HS50 Diagnostic Ultrasound System, HS60 Diagnostic Ultrasound System
IYN
System, Imaging, Pulsed Doppler, Ultrasonic
88d
Cleared
Apr 09, 2021
RT Elements, Cranial SRS w/ Cones, Multiple Brain Mets SRS, Cranial SRS, Spine SRS, RT QA, Dose Review
MUJ
System, Planning, Radiation Therapy Treatment
113d
Cleared
Apr 08, 2021
CW120N
PGY
Display, Diagnostic Radiology
48d
Cleared
Apr 02, 2021
Eclipse II with Smart Noise Cancellation
MQB
Solid State X-ray Imager (flat Panel/digital Imager)
219d
Cleared
Apr 01, 2021
ACUSON Redwood Diagnostic Ultrasound System
IYN
System, Imaging, Pulsed Doppler, Ultrasonic
20d
Cleared
Apr 01, 2021
Vantage Orian 1.5T, MRT-1550, V6.0 with AiCE Reconstruction Processing Unit for MR
LNH
System, Nuclear Magnetic Resonance Imaging
55d
Cleared
Mar 31, 2021
MAGNETOM Vida, MAGNETOM Sola, MAGNETOM Lumina, MAGNETOM Altea
LNH
System, Nuclear Magnetic Resonance Imaging
128d
Cleared
Mar 31, 2021
syngo.CT Lung CAD
OEB
Lung Computed Tomography System, Computer-aided Detection
146d
Cleared
Mar 29, 2021
StarGuide
KPS
System, Tomography, Computed, Emission
66d
Cleared
Mar 24, 2021
Aquilion ONE (TSX-306A/3) V10.4 with Spectral Imaging System
JAK
System, X-ray, Tomography, Computed
142d
Cleared
Mar 23, 2021
TE7/TE5/TE7 Max/TE5 Max/TE9 Diagnostic Ultrasound System
IYN
System, Imaging, Pulsed Doppler, Ultrasonic
125d
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