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
148d
Avg (2y)
1976
Since
12503 Radiology devices
Cleared
Apr 22, 2016
sterEOS Workstation
LLZ
System, Image Processing, Radiological
21d
Cleared
Apr 22, 2016
Anzai Respiratory Gating System
LHN
System, Radiation Therapy, Charged-particle, Medical
66d
Cleared
Apr 22, 2016
MX50N(MX50YQS)
PGY
Display, Diagnostic Radiology
74d
Cleared
Apr 21, 2016
PROBEAT-V and accessories
LHN
System, Radiation Therapy, Charged-particle, Medical
126d
Cleared
Apr 20, 2016
Leksell Gamma Knife Icon
IWB
System, Radiation Therapy, Radionuclide
63d
Cleared
Apr 19, 2016
Fujifilm Sonosite Vevo MD Imaging System
IYN
System, Imaging, Pulsed Doppler, Ultrasonic
40d
Cleared
Apr 19, 2016
AIRO Computed Tomography (CT) X-ray System
JAK
System, X-ray, Tomography, Computed
90d
Cleared
Apr 15, 2016
Morpheus RealTime Ultrasound, Pathway RealTime Ultrasound, QuickScan Bladder Ultrasound
IYO
System, Imaging, Pulsed Echo, Ultrasonic
23d
Cleared
Apr 15, 2016
RIOScan (RPS500)
MUH
System, X-ray, Extraoral Source, Digital
24d
Cleared
Apr 15, 2016
MAGNETOM Aera, MAGNETOM Skyra, MAGNETOM Prisma, MAGNETOM Prisma fit
LNH
System, Nuclear Magnetic Resonance Imaging
148d
Cleared
Apr 14, 2016
CX30N (CX30PQX)
PGY
Display, Diagnostic Radiology
66d
Cleared
Apr 14, 2016
MX30N(MX30TQS)
PGY
Display, Diagnostic Radiology
66d
Cleared
Apr 13, 2016
Varian Sterilization Boxes
JAQ
System, Applicator, Radionuclide, Remote-controlled
99d
Cleared
Apr 13, 2016
DICOM Viewer
LLZ
System, Image Processing, Radiological
114d
Cleared
Apr 12, 2016
EndoSize
LLZ
System, Image Processing, Radiological
62d
Cleared
Apr 08, 2016
Xmaru View V1 and Xmaru PACS, Medical Image Processing Software
LLZ
System, Image Processing, Radiological
38d
Cleared
Apr 08, 2016
spineEOS
LLZ
System, Image Processing, Radiological
52d
Cleared
Apr 08, 2016
RayStation
MUJ
System, Planning, Radiation Therapy Treatment
80d
Cleared
Apr 08, 2016
Bladder Scanner
IYO
System, Imaging, Pulsed Echo, Ultrasonic
115d
Cleared
Apr 08, 2016
FDR D-EVO flat Panel Detector System
MQB
Solid State X-ray Imager (flat Panel/digital Imager)
129d
Cleared
Apr 08, 2016
Philips Multislice CT System with Low Dose CT Lung Cancer
JAK
System, X-ray, Tomography, Computed
133d
Cleared
Apr 07, 2016
CX20N(CX20PUX)
PGY
Display, Diagnostic Radiology
59d
Cleared
Apr 07, 2016
CX50N, CX50YQS
PGY
Display, Diagnostic Radiology
59d
Cleared
Apr 07, 2016
SIGMA P5/ OMEGA P7/ LAMBDA P9 Portable Ultrasound Diagnostic Scanner
IYN
System, Imaging, Pulsed Doppler, Ultrasonic
59d
Cleared
Apr 06, 2016
EPIQ 5 Diagnostic Ultrasound System, EPIQ 7Diagnostic Ultrasound System, Affiniti 50 Diagnostic Ultrasound System, Affiniti 70 Diagnostic Ultrasound System
IYN
System, Imaging, Pulsed Doppler, Ultrasonic
13d
Looking for a specific radiology device? Search by device name, K-number or manufacturer.
Search all Radiology 510(k) devices