FDA 510(k) Radiology Devices
FDA 510(k) Radiology Devices - Regulatory Overview
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
15507
Total
15488
Cleared
146d
Avg (2y)
1976
Since
4605 Radiology devices
Cleared
Mar 18, 2020
VIVIX-S VW
MQB
Solid State X-ray Imager (flat Panel/digital Imager)
27d
Cleared
Mar 18, 2020
Viz ICH
QAS
Radiological Computer-assisted Triage And Notification Software
79d
Cleared
Mar 17, 2020
Shear Wave Quantificational Ultrasound Diagnostic System
IYO
System, Imaging, Pulsed Echo, Ultrasonic
56d
Cleared
Mar 16, 2020
Al-Rad Companion (Musculoskeletal)
JAK
System, X-ray, Tomography, Computed
111d
Cleared
Mar 16, 2020
OptikView GUP2103CMI
PGY
Display, Diagnostic Radiology
264d
Cleared
Mar 13, 2020
CS 9600
OAS
X-ray, Tomography, Computed, Dental
49d
Cleared
Mar 13, 2020
32HL512D
PGY
Display, Diagnostic Radiology
149d
Cleared
Mar 13, 2020
EzOrtho
LLZ
System, Image Processing, Radiological
155d
Cleared
Mar 12, 2020
SonoVision Ultrasound Imaging System
IYN
System, Imaging, Pulsed Doppler, Ultrasonic
191d
Cleared
Mar 12, 2020
RefleXion Medical Radiotherapy System
IYE
Accelerator, Linear, Medical
332d
Cleared
Mar 11, 2020
MAGNETOM Vida, MAGNETOM Lumina, MAGNETOM Vida Fit
LNH
System, Nuclear Magnetic Resonance Imaging
147d
Cleared
Mar 09, 2020
DR 600 with Tomosynthesis
IZF
System, X-ray, Tomographic
104d
Cleared
Mar 09, 2020
syngo.CT Lung CAD
OEB
Lung Computed Tomography System, Computer-aided Detection
109d
Cleared
Mar 09, 2020
Vantage Galan 3T, MRT-3020, V6.0 with AiCE Reconstruction Processing Unit for MR
LNH
System, Nuclear Magnetic Resonance Imaging
172d
Cleared
Mar 06, 2020
Insight Enhanced DRF Digital Imaging System
JAA
System, X-ray, Fluoroscopic, Image-intensified
17d
Cleared
Mar 06, 2020
EPIQ Diagnostic Ultrasound System
IYN
System, Imaging, Pulsed Doppler, Ultrasonic
29d
Cleared
Mar 05, 2020
TrackX
OWB
Interventional Fluoroscopic X-ray System
21d
Cleared
Mar 05, 2020
Transpara
QDQ
Radiological Computer Assisted Detection/diagnosis Software For Lesions Suspicious For Cancer
104d
Cleared
Mar 05, 2020
ProVecta 3D Prime Ceph
OAS
X-ray, Tomography, Computed, Dental
113d
Cleared
Mar 05, 2020
CURA 778
JAK
System, X-ray, Tomography, Computed
167d
Cleared
Mar 05, 2020
Kinepict Medical Imaging Tool version v2.2
LLZ
System, Image Processing, Radiological
324d
Cleared
Mar 04, 2020
Broncholab
JAK
System, X-ray, Tomography, Computed
266d
Cleared
Mar 02, 2020
Vantage Galan 3T, MRT-3020, V6.0
LNH
System, Nuclear Magnetic Resonance Imaging
172d
Cleared
Feb 28, 2020
R-Sensor, R-Sensor
MUH
System, X-ray, Extraoral Source, Digital
23d
Cleared
Feb 28, 2020
CT F/S/D Compatible Applicators (Fletcher), HDR Compatible Tandem and Ovoid Applicators (Henschke), HDR CT Compatible Split Ring Applicator, Segmented Vaginal Applicator, HDR Miami Applicator HDR Brachytherapy Applicator, 2/3 Endometrial Applicator Sets, CT HDR Ring & Tandem Applicator with Rectal Retractor
JAQ
System, Applicator, Radionuclide, Remote-controlled
30d
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