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
12554 Radiology devices
Cleared
Nov 29, 2013
LESSRAY
OWB
Interventional Fluoroscopic X-ray System
67d
Cleared
Nov 27, 2013
UGEO WS80A DIAGNOSTIC ULTRASOUND SYSTEM
IYN
System, Imaging, Pulsed Doppler, Ultrasonic
29d
Cleared
Nov 27, 2013
E-CUBE 7
IYN
System, Imaging, Pulsed Doppler, Ultrasonic
91d
Cleared
Nov 27, 2013
MYLABSEVEN, MYLABALPHA
IYN
System, Imaging, Pulsed Doppler, Ultrasonic
132d
Cleared
Nov 27, 2013
JUSHA-M52C MEDICAL DISPLAY
LLZ
System, Image Processing, Radiological
197d
Cleared
Nov 25, 2013
CHARRUAPACS SYSTEM
LLZ
System, Image Processing, Radiological
25d
Cleared
Nov 25, 2013
TOMTEC-ARENA 1.0, TOMTEC-ARENA 3D ECHO, CARDIO-ARENA
LLZ
System, Image Processing, Radiological
104d
Cleared
Nov 25, 2013
FDR D-EVO FLAT PANEL DETECTOR SYSTEM
MQB
Solid State X-ray Imager (flat Panel/digital Imager)
105d
Cleared
Nov 22, 2013
MAGNETOM PRISMA, MAGNETOM PRISMA FIT
LNH
System, Nuclear Magnetic Resonance Imaging
136d
Cleared
Nov 20, 2013
MONACO
MUJ
System, Planning, Radiation Therapy Treatment
58d
Cleared
Nov 20, 2013
I2C
LHN
System, Radiation Therapy, Charged-particle, Medical
70d
Cleared
Nov 20, 2013
MULTICAM 3000 ECO
KPS
System, Tomography, Computed, Emission
114d
Cleared
Nov 20, 2013
MRI MARKER
KXK
Source, Brachytherapy, Radionuclide
163d
Cleared
Nov 19, 2013
DC-N2/DC-N2S DIAGNOSTIC ULTRASOUND SYSTEM
IYN
System, Imaging, Pulsed Doppler, Ultrasonic
75d
Cleared
Nov 19, 2013
SUMITOMO PROTON THERAPY SYSTEM
LHN
System, Radiation Therapy, Charged-particle, Medical
272d
Cleared
Nov 18, 2013
DISCOVERY XR656 WITH VOLUMERAD (DIGITAL TOMOSYNTHESIS)
IZF
System, X-ray, Tomographic
122d
Cleared
Nov 15, 2013
VOLCANO LOMAP,VOLCANO LOMAP OPTION KIT FOR MOBILE SYSTEM,VOLCANO LOMAP OPTION FOR INTEGRATED SYSTEM,VOLCANO S5 PRECISION
IYO
System, Imaging, Pulsed Echo, Ultrasonic
29d
Cleared
Nov 15, 2013
MAGNETOM AERA
LNH
System, Nuclear Magnetic Resonance Imaging
57d
Cleared
Nov 15, 2013
DISCOVERY MR750 3.0T, DISCOVERY MR450 1.5T, DISCOVERY MR750W 3.0T, OPTIMA MR450W 1.5T
LNH
System, Nuclear Magnetic Resonance Imaging
108d
Cleared
Nov 14, 2013
DOSIMETRY CHECK VERSION 4 RELEASE 1
IYE
Accelerator, Linear, Medical
86d
Cleared
Nov 14, 2013
DIGITAL COLOR DOPPLER ULTASOUND SYSTEM
IYN
System, Imaging, Pulsed Doppler, Ultrasonic
94d
Cleared
Nov 12, 2013
BIOGRAPH MMR
OUO
Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance
22d
Cleared
Nov 12, 2013
GALAXY AND GALAXY+PLUS DIGITAL RADIOGRAPHY SYSTEMS
KPR
System, X-ray, Stationary
112d
Cleared
Nov 12, 2013
INFINIX ANGIO WORKSTATION W/DTS SOFTWARE
JAA
System, X-ray, Fluoroscopic, Image-intensified
127d
Cleared
Nov 08, 2013
VOLUSON E6 / E8 / E8EXPERT / E8EXPERT LIMITED EDITION / E10
IYN
System, Imaging, Pulsed Doppler, Ultrasonic
52d
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