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
4632 Radiology devices
Cleared
Aug 07, 2015
syngo.MR Neurology, syngo.MR Oncology
LLZ
System, Image Processing, Radiological
79d
Cleared
Aug 06, 2015
O-Arm O2 Imaging System
OWB
Interventional Fluoroscopic X-ray System
113d
Cleared
Jul 17, 2015
Biograph mCT and mCT Flow PET/CT Scanners
KPS
System, Tomography, Computed, Emission
45d
Cleared
Jun 23, 2015
syngo.via MI Workflows
LLZ
System, Image Processing, Radiological
50d
Cleared
May 18, 2015
syngo.CT Dental
JAK
System, X-ray, Tomography, Computed
54d
Cleared
Apr 16, 2015
SOMATOM Definition Flash (VA48)
JAK
System, X-ray, Tomography, Computed
139d
Cleared
Apr 08, 2015
SOMATOM Definition AS/AS+
JAK
System, X-ray, Tomography, Computed
131d
Cleared
Apr 06, 2015
SOMATOM Definition Edge
JAK
System, X-ray, Tomography, Computed
129d
Cleared
Mar 30, 2015
Site-Rite Prevue Ultrasound System, Site-Rite Prevue+ Ultrasound System
IYO
System, Imaging, Pulsed Echo, Ultrasonic
28d
Cleared
Mar 29, 2015
Scenium
LLZ
System, Image Processing, Radiological
60d
Cleared
Mar 26, 2015
SOMATOM Definition AS Open (VA48)
JAK
System, X-ray, Tomography, Computed
118d
Cleared
Feb 09, 2015
ACUSON P500 Diagnostic Ultrasound System
IYN
System, Imaging, Pulsed Doppler, Ultrasonic
28d
Cleared
Jan 16, 2015
iMAR
JAK
System, X-ray, Tomography, Computed
123d
Cleared
Dec 18, 2014
MULTIX FUSION VA30 & VA40
KPR
System, X-ray, Stationary
143d
Cleared
Dec 10, 2014
eSie Apps Suite
LLZ
System, Image Processing, Radiological
27d
Cleared
Dec 03, 2014
SYNGO.CT COLONOGRAPHY
NWE
Colon Computed Tomography System, Computer Aided Detection
237d
Cleared
Nov 21, 2014
ARTISTE SOLUTION, SYS_VC10C, PHASE 2 UPDATE WITH THE SYNGO RT THERAPIST & RT ONCOLOGIST WORKSPACES, V4.3.1_MR1
IYE
Accelerator, Linear, Medical
84d
Cleared
Nov 19, 2014
MAGNETOM AERA WITH SOFTWARE SYNGO MR E11A, MAGNETOM SKYRA WITH SOFTWARE SYNGO MR E11A, MAGNETOM SKYRA WITH 24 RF CHANNEL
LNH
System, Nuclear Magnetic Resonance Imaging
121d
Cleared
Oct 30, 2014
Site-Rite 6 Ultrasound System with Pinpoint GT Technology
IYO
System, Imaging, Pulsed Echo, Ultrasonic
58d
Cleared
Oct 23, 2014
ACUSON S1000/ S2000/ S3000 Diagnostic Ultrasound Systems
IYN
System, Imaging, Pulsed Doppler, Ultrasonic
22d
Cleared
Oct 16, 2014
SYNGO CT SINGLE SOURCE DUAL ENERGY
JAK
System, X-ray, Tomography, Computed
321d
Cleared
Oct 08, 2014
MAGNETOM Combi Suite Neurosurgery for the MAGNETOM Aera, MAGNETOM Combi Suite Neurosurgery for the MAGNETOM Skyra
LNH
System, Nuclear Magnetic Resonance Imaging
30d
Cleared
Sep 15, 2014
SOMATOM SCOPE/SOMATOM SCOPE POWER
JAK
System, X-ray, Tomography, Computed
159d
Cleared
Sep 12, 2014
BIOGRAPH TRUE PET/CT FAMILY SOFTWARE
KPS
System, Tomography, Computed, Emission
53d
Cleared
Sep 09, 2014
SC2000 and ACUSON X300 Diagnostic Ultrasound Systems
IYO
System, Imaging, Pulsed Echo, Ultrasonic
13d
Looking for a specific radiology device? Search by device name, K-number or manufacturer.
Search all Radiology 510(k) devices