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
4636 Radiology devices
Cleared
Sep 05, 2014
ARTIS ZEE/ZEEGO SW VC21
OWB
Interventional Fluoroscopic X-ray System
85d
Cleared
Aug 21, 2014
SYMBIA 6.0
KPS
System, Tomography, Computed, Emission
29d
Cleared
Aug 14, 2014
SYNGO CT 2014A (SOMARIS/5 VB42) FOR SOMATOM EMOTION & SENSATION FAMILY CT
JAK
System, X-ray, Tomography, Computed
196d
Cleared
Aug 07, 2014
ACUSON X700 ULTRASOUND SYSTEM, ACUSON X600 ULTRASOUND SYSTEM
IYN
System, Imaging, Pulsed Doppler, Ultrasonic
29d
Cleared
Jul 18, 2014
SYNGO.MR NEUROLOGY, SYNGO.MMR GENERAL
LLZ
System, Image Processing, Radiological
102d
Cleared
Jul 11, 2014
ESIE APPS SUITE
LLZ
System, Image Processing, Radiological
30d
Cleared
Jul 07, 2014
SYNGO, CT DUAL ENERGY
JAK
System, X-ray, Tomography, Computed
222d
Cleared
May 02, 2014
BRACHYSOURCE SEED IMPLANTS WITH SOURCECAP BIOABSORBABLE CAPS
KXK
Source, Brachytherapy, Radionuclide
29d
Cleared
Apr 30, 2014
ACUSON S1000, S2000, S3000 DIAGNOSTIC ULTRASOUND SYSTEMS
IYN
System, Imaging, Pulsed Doppler, Ultrasonic
15d
Cleared
Apr 30, 2014
SOMATOM PERSPECTIVE
JAK
System, X-ray, Tomography, Computed
159d
Cleared
Apr 28, 2014
ARTIS ONE
OWB
Interventional Fluoroscopic X-ray System
158d
Cleared
Apr 17, 2014
SOMATOM FORCE
JAK
System, X-ray, Tomography, Computed
146d
Cleared
Apr 07, 2014
SYNGO DUAL ENERGY SOFTWARE PACKAGE
JAK
System, X-ray, Tomography, Computed
203d
Cleared
Mar 20, 2014
MAGNETOM ARTIS COMBI SUITE FOR THE MAGNETOM AERA/SKYRA/SKYRA WITH TIMTX TRUESHAPE
LNH
System, Nuclear Magnetic Resonance Imaging
48d
Cleared
Mar 11, 2014
SYNO MR NEUROLOGY, SYNGO MR ONCOLOGY, SYNGO. MR BREVIS, SYNGO MMR GENERAL
LLZ
System, Image Processing, Radiological
125d
Cleared
Feb 28, 2014
SCENIUM
LLZ
System, Image Processing, Radiological
93d
Cleared
Feb 25, 2014
SYNGO.VIA MI WORKFLOWS
LLZ
System, Image Processing, Radiological
90d
Cleared
Feb 21, 2014
ARTISTE SOLUTION WITH SYS_VC10C AND SYNGO RT THERAPIST WORKSPACE, V4.3.1 UPGRADE KIT, ARIA CONNECTIVITY OPTION FOR SIEME
IYE
Accelerator, Linear, Medical
156d
Cleared
Jan 24, 2014
YSIO MAX
KPR
System, X-ray, Stationary
93d
Cleared
Jan 17, 2014
SOMATOM EMOTION 6 CT SYSTEMS, SOMATOM EMOTION 16
JAK
System, X-ray, Tomography, Computed
70d
Cleared
Dec 24, 2013
ACUSON
IYN
System, Imaging, Pulsed Doppler, Ultrasonic
244d
Cleared
Dec 12, 2013
MAGNETOM AERA AND SKYRA WITH SOFTWARE MR D13A
LNH
System, Nuclear Magnetic Resonance Imaging
34d
Cleared
Nov 22, 2013
MAGNETOM PRISMA, MAGNETOM PRISMA FIT
LNH
System, Nuclear Magnetic Resonance Imaging
136d
Cleared
Nov 15, 2013
MAGNETOM AERA
LNH
System, Nuclear Magnetic Resonance Imaging
57d
Cleared
Nov 12, 2013
BIOGRAPH MMR
OUO
Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance
22d
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