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
Apr 08, 2016
Philips Multislice CT System with Low Dose CT Lung Cancer
JAK
System, X-ray, Tomography, Computed
133d
Cleared
Mar 31, 2016
MAGNETOM Spectra
LNH
System, Nuclear Magnetic Resonance Imaging
125d
Cleared
Mar 25, 2016
SOMATOM Perspective
JAK
System, X-ray, Tomography, Computed
269d
Cleared
Mar 18, 2016
somatom Scope(with syngo CT VC30-easyIQ version), SOMATOM Scope Power(with syngo CT VC30-easyIQ version)
JAK
System, X-ray, Tomography, Computed
263d
Cleared
Mar 07, 2016
Cios Fusion
OWB
Interventional Fluoroscopic X-ray System
119d
Cleared
Mar 04, 2016
syngo.via MI Workflows
LLZ
System, Image Processing, Radiological
17d
Cleared
Mar 04, 2016
syngo Application Software VD11
LLZ
System, Image Processing, Radiological
105d
Cleared
Feb 29, 2016
syngo.via MI Workflows
LLZ
System, Image Processing, Radiological
24d
Cleared
Feb 19, 2016
syngo.CT Single Source Dual Energy (Twin Beam)
JAK
System, X-ray, Tomography, Computed
105d
Cleared
Feb 10, 2016
Cios Select
OWB
Interventional Fluoroscopic X-ray System
93d
Cleared
Jan 12, 2016
Cios Connect
OWB
Interventional Fluoroscopic X-ray System
74d
Cleared
Jan 12, 2016
Biograph Horizon PET/CT
KPS
System, Tomography, Computed, Emission
104d
Cleared
Dec 24, 2015
MAGNETOM Amira
LNH
System, Nuclear Magnetic Resonance Imaging
134d
Cleared
Dec 14, 2015
Site-Rite 8 Ultrasound System, Site-Rite 8 Ultrasound System with Pinpoint GT Technology
IYO
System, Imaging, Pulsed Echo, Ultrasonic
97d
Cleared
Nov 24, 2015
SOMATOM Force, SOMATOM Definition Flash, SOMATOM Definition Edge, SOMATOM Definition AS/AS+, SOMATOM Definition AS Open, SOMATON Emotion 6/16, SOMATOM Sensation 64/Sensation Cardiac , SOMATOM Perspective SOMATOM Scope/ Scope Power
JAK
System, X-ray, Tomography, Computed
406d
Cleared
Nov 13, 2015
Multitom Rax
OWB
Interventional Fluoroscopic X-ray System
39d
Cleared
Nov 12, 2015
SOMATOM Emotion 6/16
JAK
System, X-ray, Tomography, Computed
136d
Cleared
Nov 02, 2015
syngo.CT Myocardial Perfusion
JAK
System, X-ray, Tomography, Computed
228d
Cleared
Oct 09, 2015
SOMATOM Definition Edge, SOMATOM Definition AS/AS+
JAK
System, X-ray, Tomography, Computed
79d
Cleared
Sep 29, 2015
MAGNETOM Aera (24-channel), MAGNETOM Avanto fit, MAGNETOM Skyra fit, MAGNETOM Prisma, MAGNETOM Prisma fit
LNH
System, Nuclear Magnetic Resonance Imaging
110d
Cleared
Sep 16, 2015
syngo VSim
MUJ
System, Planning, Radiation Therapy Treatment
68d
Cleared
Sep 14, 2015
MAMMOMAT Fusion
MUE
Full Field Digital, System, X-ray, Mammographic
88d
Cleared
Aug 13, 2015
syngo.via RT Image Suite
MUJ
System, Planning, Radiation Therapy Treatment
83d
Cleared
Aug 11, 2015
syngo.CT Dual Energy
JAK
System, X-ray, Tomography, Computed
141d
Cleared
Aug 11, 2015
syngo.CT Single Source Dual Energy
JAK
System, X-ray, Tomography, Computed
141d
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