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
1598 Radiology devices
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
Cleared
Apr 01, 2022
Wireless Digital Flat Panel Detector
MQB
Solid State X-ray Imager (flat Panel/digital Imager)
25d
Cleared
Apr 01, 2022
MAGNETOM Avanto Fit
LNH
System, Nuclear Magnetic Resonance Imaging
72d
Cleared
Mar 29, 2022
Focus HD 35 Detector
MQB
Solid State X-ray Imager (flat Panel/digital Imager)
145d
Cleared
Mar 29, 2022
Focus HD 43 Detector
MQB
Solid State X-ray Imager (flat Panel/digital Imager)
145d
Cleared
Mar 28, 2022
Syngo.CT Dual Energy
JAK
System, X-ray, Tomography, Computed
199d
Cleared
Mar 25, 2022
TEX20/TEX20 Pro/TEX20S/TEX20T/TEX20 Exp/TEX20 Elite, TEX10/ TEX10 Pro/TEX10S/TEX10T/TEX10 Exp/TEX10 Elite/TE X/TE X Lite Diagnostic Ultrasound System
IYN
System, Imaging, Pulsed Doppler, Ultrasonic
56d
Cleared
Mar 25, 2022
DTX Studio Clinic 3.0
LLZ
System, Image Processing, Radiological
136d
Cleared
Mar 25, 2022
C1210G LCD Monitor, JUSHA-C1210G LCD Monitor, C1210 LCD Monitor, JUSHA-C1210 LCD Monitor
PGY
Display, Diagnostic Radiology
252d
Cleared
Mar 22, 2022
LOGIQ P10, LOGIQ P9, LOGIQ P8
IYN
System, Imaging, Pulsed Doppler, Ultrasonic
89d
Cleared
Mar 22, 2022
Aplio a550, Aplio a450, and Aplio a, Diagnostic Ultrasound System, Software V6.5
IYN
System, Imaging, Pulsed Doppler, Ultrasonic
187d
Cleared
Mar 21, 2022
BriefCase
QAS
Radiological Computer-assisted Triage And Notification Software
117d
Cleared
Mar 14, 2022
BriefCase
QFM
Radiological Computer-assisted Prioritization Software For Lesions
81d
Cleared
Mar 11, 2022
MAGNETOM Vida, MAGNETOM Sola
LNH
System, Nuclear Magnetic Resonance Imaging
25d
Cleared
Mar 11, 2022
Dental sensors NanoPix1, NanoPix2
MUH
System, X-ray, Extraoral Source, Digital
25d
Cleared
Mar 11, 2022
CardIQ Suite
JAK
System, X-ray, Tomography, Computed
105d
Cleared
Mar 11, 2022
RI.HIP MODELER
LLZ
System, Image Processing, Radiological
254d
Cleared
Mar 09, 2022
ZEN-2090 Turbo
OWB
Interventional Fluoroscopic X-ray System
273d
Cleared
Mar 07, 2022
syngo.CT Applications
JAK
System, X-ray, Tomography, Computed
18d
Cleared
Mar 04, 2022
TE Air Diagnostic Ultrasound System
IYN
System, Imaging, Pulsed Doppler, Ultrasonic
57d
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