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
1592 Radiology devices
Cleared
May 17, 2022
BriefCase
QAS
Radiological Computer-assisted Triage And Notification Software
18d
Cleared
May 17, 2022
syngo.CT CaScoring
JAK
System, X-ray, Tomography, Computed
20d
Cleared
May 17, 2022
MULTIX Impact E
KPR
System, X-ray, Stationary
48d
Cleared
May 17, 2022
Rapid PE Triage and Notification (PETN)
QAS
Radiological Computer-assisted Triage And Notification Software
84d
Cleared
May 16, 2022
Achieva, Ingenia, Ingenia CX, Ingenia Elition and Ingenia Ambition MR Systems
LNH
System, Nuclear Magnetic Resonance Imaging
185d
Cleared
May 16, 2022
Caas Qardia
LLZ
System, Image Processing, Radiological
290d
Cleared
May 13, 2022
MAGNETOM Skyra Fit
LNH
System, Nuclear Magnetic Resonance Imaging
73d
Cleared
May 13, 2022
Spectral CT on Rails
JAK
System, X-ray, Tomography, Computed
246d
Cleared
May 11, 2022
Versana Balance
IYN
System, Imaging, Pulsed Doppler, Ultrasonic
84d
Cleared
May 10, 2022
RadiForce MX243W
PGY
Display, Diagnostic Radiology
21d
Cleared
May 06, 2022
NewTom 7G
JAK
System, X-ray, Tomography, Computed
60d
Cleared
May 06, 2022
HM70 EVO Diagnostic Ultrasound System
IYN
System, Imaging, Pulsed Doppler, Ultrasonic
95d
Cleared
May 05, 2022
17HQ901G-B
MQB
Solid State X-ray Imager (flat Panel/digital Imager)
66d
Cleared
May 02, 2022
Liver Suite
JAK
System, X-ray, Tomography, Computed
377d
Cleared
Apr 29, 2022
MAGNETOM Lumina and MAGNETOM Vida Fit with syngo MR XA50A
LNH
System, Nuclear Magnetic Resonance Imaging
29d
Cleared
Apr 29, 2022
ExacTrac Dynamic
IYE
Accelerator, Linear, Medical
81d
Cleared
Apr 28, 2022
Digital flat panel detector
MQB
Solid State X-ray Imager (flat Panel/digital Imager)
63d
Cleared
Apr 28, 2022
Planmed Verity
OAS
X-ray, Tomography, Computed, Dental
209d
Cleared
Apr 26, 2022
BriefCase
QAS
Radiological Computer-assisted Triage And Notification Software
134d
Cleared
Apr 21, 2022
GM85
IZL
System, X-ray, Mobile
90d
Cleared
Apr 18, 2022
Nautilus
JAA
System, X-ray, Fluoroscopic, Image-intensified
24d
Cleared
Apr 15, 2022
AI-Rad Companion Brain MR
QIH
Automated Radiological Image Processing Software
142d
Cleared
Apr 08, 2022
Vantage Galan 3T, MRT-3020, V8.0 with AiCE Reconstruction Processing Unit for MR
LNH
System, Nuclear Magnetic Resonance Imaging
74d
Cleared
Apr 05, 2022
Vantage Fortian/Orian 1.5T, MRT-1550, V8.0 with AiCE Reconstruction Processing Unit for MR
LNH
System, Nuclear Magnetic Resonance Imaging
57d
Cleared
Apr 05, 2022
HERA W10 Diagnostic Ultrasound System, HERA W9 Diagnostic Ultrasound System
IYN
System, Imaging, Pulsed Doppler, Ultrasonic
90d
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