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
1587 Radiology devices
Cleared
Mar 07, 2023
Aquilion Precision (TSX-304A/4) V10.14 with AiCE
JAK
System, X-ray, Tomography, Computed
84d
Cleared
Mar 03, 2023
Aquilion Serve (TSX-307A/1) V1.2 with AiCE-i
JAK
System, X-ray, Tomography, Computed
165d
Cleared
Mar 02, 2023
FibroScan® device (Models: 502 Touch, 530 Compact, 430 Mini+, 230, and 630)
IYO
System, Imaging, Pulsed Echo, Ultrasonic
64d
Cleared
Mar 02, 2023
1.5T 24E Posterior Array
LNH
System, Nuclear Magnetic Resonance Imaging
139d
Cleared
Mar 02, 2023
Rapid NCCT Stroke
QAS
Radiological Computer-assisted Triage And Notification Software
161d
Cleared
Mar 01, 2023
32HQ713D
PGY
Display, Diagnostic Radiology
107d
Cleared
Mar 01, 2023
Xeleris V Processing and Review System
LLZ
System, Image Processing, Radiological
265d
Cleared
Feb 24, 2023
AVIEW Lung Nodule CAD
OEB
Lung Computed Tomography System, Computer-aided Detection
267d
Cleared
Feb 24, 2023
MAGNETOM Vida
LNH
System, Nuclear Magnetic Resonance Imaging
445d
Cleared
Feb 23, 2023
Monaco RTP System
MUJ
System, Planning, Radiation Therapy Treatment
127d
Cleared
Feb 23, 2023
MOSAIQ® OIS (Oncology Information System)
IYE
Accelerator, Linear, Medical
128d
Cleared
Feb 23, 2023
Elekta Unity
IYE
Accelerator, Linear, Medical
129d
Cleared
Feb 23, 2023
Brainomix 360 e-ASPECTS
POK
Computer-assisted Diagnostic Software For Lesions Suspicious For Cancer
268d
Cleared
Feb 22, 2023
Swoop® Portable MR Imaging System™
LNH
System, Nuclear Magnetic Resonance Imaging
28d
Cleared
Feb 17, 2023
EzDent-i / E2 / Prora View/ Smart M Viewer
LLZ
System, Image Processing, Radiological
58d
Cleared
Feb 16, 2023
uCT ATLAS Astound with uWS-CT-Dual Energy Analysis
JAK
System, X-ray, Tomography, Computed
140d
Cleared
Feb 15, 2023
Digital Radiography CXDI-CS01
MQB
Solid State X-ray Imager (flat Panel/digital Imager)
26d
Cleared
Feb 15, 2023
Versana Essential
IYN
System, Imaging, Pulsed Doppler, Ultrasonic
98d
Cleared
Feb 14, 2023
8ch T/R Knee Coil
MOS
Coil, Magnetic Resonance, Specialty
119d
Cleared
Feb 13, 2023
ACUSON Juniper Diagnostic Ultrasound System, ACUSON Juniper Select Diagnostic Ultrasound System
IYN
System, Imaging, Pulsed Doppler, Ultrasonic
19d
Cleared
Feb 13, 2023
syngo.via View&GO VA40A
LLZ
System, Image Processing, Radiological
19d
Cleared
Feb 13, 2023
V8 Diagnostic Ultrasound System, V7 Diagnostic Ultrasound System
IYN
System, Imaging, Pulsed Doppler, Ultrasonic
98d
Cleared
Feb 10, 2023
S90 Exp Series Digital Color Doppler Ultrasound System
IYN
System, Imaging, Pulsed Doppler, Ultrasonic
168d
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
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