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
Jan 06, 2022
TOMTEC-ARENA
QIH
Automated Radiological Image Processing Software
59d
Cleared
Dec 27, 2021
Sonosite PX Ultrasound System
IYN
System, Imaging, Pulsed Doppler, Ultrasonic
26d
Cleared
Dec 23, 2021
dS FootAnkle 16Ch Coils for 1.5T and 3.0T, dS HiRes HandWrist 16Ch Coils for 1.5T and 3.0T, ds Small Extremity 16Ch Coils for 1.5T and 3.0T
MOS
Coil, Magnetic Resonance, Specialty
22d
Cleared
Dec 17, 2021
Revolution Apex, Revolution Apex Elite, Revolution Apex Plus, Revolution Apex Select,Revolution CT
JAK
System, X-ray, Tomography, Computed
23d
Cleared
Dec 16, 2021
6MP Color LCD Monitor CL-S600
PGY
Display, Diagnostic Radiology
90d
Cleared
Dec 16, 2021
Brainlab Elements, Brainlab Elements Contouring, Brainlab Elements Fibertracking, Brainlab Elements Image Fusion, Brainlab Elements Image Fusion Angio
LLZ
System, Image Processing, Radiological
134d
Cleared
Dec 13, 2021
MULTIX Impact, MULTIX Impact C
KPR
System, X-ray, Stationary
20d
Cleared
Dec 10, 2021
X-Clever
LLZ
System, Image Processing, Radiological
155d
Cleared
Dec 06, 2021
Al-Rad Companion (Pulmonary)
JAK
System, X-ray, Tomography, Computed
73d
Cleared
Dec 03, 2021
21HQ513D
PGY
Display, Diagnostic Radiology
134d
Cleared
Dec 01, 2021
Vantage Fortian 1.5T, MRT-1550, V8.0 with AiCE Reconstruction Processing Unit for MR
LNH
System, Nuclear Magnetic Resonance Imaging
58d
Cleared
Nov 29, 2021
RCT700
OAS
X-ray, Tomography, Computed, Dental
61d
Cleared
Nov 19, 2021
MR 5300
LNH
System, Nuclear Magnetic Resonance Imaging
87d
Cleared
Nov 16, 2021
TEX20/TEX20 Pro/TEX20S/TEX20T/TEX20 Exp/TEX20 Elite Diagnostic Ultrasound System, TEX10/ TEX10 Pro/TEX10S/TEX10T/TEX10 Exp/TEX10 Elite/TE X/TE X Lite Diagnostic Ultrasound System
IYN
System, Imaging, Pulsed Doppler, Ultrasonic
119d
Cleared
Nov 15, 2021
Axialis Ophthalmic Ultrasound System
IYO
System, Imaging, Pulsed Echo, Ultrasonic
46d
Cleared
Nov 12, 2021
MAMMOVISTA B.smart
LLZ
System, Image Processing, Radiological
86d
Cleared
Nov 08, 2021
FDR Cross (DR-XD 3000)
OWB
Interventional Fluoroscopic X-ray System
53d
Cleared
Nov 05, 2021
MX7/MX7T/Vaus7/Zeus/ME7/Anesus ME7/Anesus ME7T/MX8/MX8T/Vaus8/ME8 Diagnostic Ultrasound System
IYN
System, Imaging, Pulsed Doppler, Ultrasonic
53d
Cleared
Nov 05, 2021
Acuson SC2000 Diagnostic Ultrasound System
IYO
System, Imaging, Pulsed Echo, Ultrasonic
154d
Cleared
Oct 29, 2021
ATEC Alignment App
LLZ
System, Image Processing, Radiological
123d
Cleared
Oct 29, 2021
Critical Care Suite with Endotracheal Tube Positing AI algorithm
QIH
Automated Radiological Image Processing Software
193d
Cleared
Oct 22, 2021
FlightPlan for Liver
LLZ
System, Image Processing, Radiological
219d
Cleared
Oct 20, 2021
Contour ProtegeAI
QKB
Radiological Image Processing Software For Radiation Therapy
231d
Cleared
Oct 18, 2021
0909FCB, 1212FCA
MQB
Solid State X-ray Imager (flat Panel/digital Imager)
48d
Cleared
Oct 07, 2021
Digital Intraoral X-ray Imaging System
MUH
System, X-ray, Extraoral Source, Digital
79d
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