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
Feb 07, 2023
Resona R9/ Resona R9 Exp/ Resona R9 Pro/ Resona R9S/ Nuewa R9/ Nuewa R9 Exp Diagnostic Ultrasound Sysem, Nuewa R9 Pro/ Nuewa R9S/ Resona 7/ Resona 7CV/Resona 7EXP/Resona 7S/ Resona 70B Diagnostic Ultrasound System, Resona 7PRO/Imagyn 7/ Resona Y/Resona R9W/Resona R7W Nuewa R9W/Nuewa R7W Diagnostic Ultrasound System
IYN
System, Imaging, Pulsed Doppler, Ultrasonic
134d
Cleared
Feb 06, 2023
ScanX Swift 2.0, ScanX Swift View 2.0
MUH
System, X-ray, Extraoral Source, Digital
25d
Cleared
Feb 06, 2023
ACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia Select Diagnostic Ultrasound System
IYN
System, Imaging, Pulsed Doppler, Ultrasonic
55d
Cleared
Feb 01, 2023
BriefCase
QFM
Radiological Computer-assisted Prioritization Software For Lesions
29d
Cleared
Feb 01, 2023
Rapid RV/LV
QIH
Automated Radiological Image Processing Software
85d
Cleared
Feb 01, 2023
LVivo IQS
QIH
Automated Radiological Image Processing Software
127d
Cleared
Jan 27, 2023
14HQ721G-B
MQB
Solid State X-ray Imager (flat Panel/digital Imager)
63d
Cleared
Jan 26, 2023
RMF-2000
MUE
Full Field Digital, System, X-ray, Mammographic
381d
Cleared
Jan 23, 2023
Clarius AI
QIH
Automated Radiological Image Processing Software
167d
Cleared
Jan 20, 2023
DRX - Compass
KPR
System, X-ray, Stationary
29d
Cleared
Jan 20, 2023
Advanced MyHip Planner
LLZ
System, Image Processing, Radiological
220d
Cleared
Jan 18, 2023
PercuNav Image Fusion and Interventional Navigation System
JAK
System, X-ray, Tomography, Computed
30d
Cleared
Jan 18, 2023
TruPlan Computed Tomography (CT) Imaging Software
LLZ
System, Image Processing, Radiological
145d
Cleared
Jan 17, 2023
MIM – Additional Tracers
LLZ
System, Image Processing, Radiological
29d
Cleared
Jan 17, 2023
hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUS
OAS
X-ray, Tomography, Computed, Dental
29d
Cleared
Jan 17, 2023
Portable X-ray System
EHD
Unit, X-ray, Extraoral With Timer
110d
Cleared
Jan 17, 2023
Halcyon, Ethos Radiotherapy System
IYE
Accelerator, Linear, Medical
113d
Cleared
Jan 13, 2023
MR Diffusion Perfusion Mismatch V1.0
LLZ
System, Image Processing, Radiological
53d
Cleared
Jan 13, 2023
Contour Knee
MOS
Coil, Magnetic Resonance, Specialty
60d
Cleared
Jan 12, 2023
MAMMOVISTA B.smart (VB70)
LLZ
System, Image Processing, Radiological
70d
Cleared
Jan 12, 2023
PreXion3D Expedition
OAS
X-ray, Tomography, Computed, Dental
176d
Cleared
Jan 09, 2023
21HQ513D
PGY
Display, Diagnostic Radiology
21d
Cleared
Jan 09, 2023
Vitrea Software Package, VSTP-002A
LLZ
System, Image Processing, Radiological
69d
Cleared
Jan 03, 2023
3.0T 16ch AIR AA
MOS
Coil, Magnetic Resonance, Specialty
57d
Cleared
Dec 22, 2022
Biograph Vision Quadra PET/CT System
KPS
System, Tomography, Computed, Emission
27d
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