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
15620
Total
15601
Cleared
147d
Avg (2y)
1976
Since
12380 Radiology devices
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
Cleared
Feb 28, 2020
Alta Multipurpose Device
IYE
Accelerator, Linear, Medical
95d
Cleared
Feb 28, 2020
icobrain-ctp
LLZ
System, Image Processing, Radiological
129d
Cleared
Feb 28, 2020
Magnetom Sola, Magnetom Altea and Magnetom Sola Fit
LNH
System, Nuclear Magnetic Resonance Imaging
170d
Cleared
Feb 28, 2020
AccuContour
QKB
Radiological Image Processing Software For Radiation Therapy
224d
Cleared
Feb 28, 2020
Red Dot
QFM
Radiological Computer-assisted Prioritization Software For Lesions
261d
Cleared
Feb 25, 2020
Ez3D-i /E3
LLZ
System, Image Processing, Radiological
32d
Cleared
Feb 25, 2020
uCT 530, uCT 550
JAK
System, X-ray, Tomography, Computed
53d
Cleared
Feb 25, 2020
SonicEye Dual-Array Ultrasound System
IYO
System, Imaging, Pulsed Echo, Ultrasonic
189d
Cleared
Feb 21, 2020
3MP Monochrome Digital Mammography LCD Monitor MS-S300
PGY
Display, Diagnostic Radiology
30d
Cleared
Feb 21, 2020
OASIS MRI System
LNH
System, Nuclear Magnetic Resonance Imaging
141d
Cleared
Feb 21, 2020
Aquilion Prime SP (TSX-303B8) V10.2 with AiCE-i
JAK
System, X-ray, Tomography, Computed
142d
Cleared
Feb 21, 2020
Beamscan MR
IYE
Accelerator, Linear, Medical
246d
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