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
12508 Radiology devices
Cleared
Dec 22, 2015
SW v3.5 Install Kit, CORE Mobile, SW v3.5 Install Kit, CORE, SW v3.5 Install Kit, s5iz
IYO
System, Imaging, Pulsed Echo, Ultrasonic
29d
Cleared
Dec 22, 2015
Philips Eleva Workspot with SkyFlow
MQB
Solid State X-ray Imager (flat Panel/digital Imager)
34d
Cleared
Dec 22, 2015
MammoGRIP
IZH
System, X-ray, Mammographic
153d
Cleared
Dec 22, 2015
Magnetic Reasonance Imaging System
LNH
System, Nuclear Magnetic Resonance Imaging
244d
Cleared
Dec 21, 2015
HM70A Diagnostic Ultrasound System
IYN
System, Imaging, Pulsed Doppler, Ultrasonic
26d
Cleared
Dec 21, 2015
GR40CW
MQB
Solid State X-ray Imager (flat Panel/digital Imager)
27d
Cleared
Dec 21, 2015
Q Series Diagnostic Ultrasound System
IYN
System, Imaging, Pulsed Doppler, Ultrasonic
56d
Cleared
Dec 17, 2015
Intraluminal Applicator Set
JAQ
System, Applicator, Radionuclide, Remote-controlled
245d
Cleared
Dec 16, 2015
ClearVue850 Diagnostic Ultrasound System
IYN
System, Imaging, Pulsed Doppler, Ultrasonic
14d
Cleared
Dec 14, 2015
OTC12D AUTO RADIOGRAPHIC SYSTEM
KPR
System, X-ray, Stationary
81d
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
Dec 14, 2015
Econsole1
LLZ
System, Image Processing, Radiological
132d
Cleared
Dec 14, 2015
QuickRay HD Intraoral Sensor
MUH
System, X-ray, Extraoral Source, Digital
153d
Cleared
Dec 11, 2015
iViewDose R1.0
IYE
Accelerator, Linear, Medical
58d
Cleared
Dec 11, 2015
DR 600
MQB
Solid State X-ray Imager (flat Panel/digital Imager)
87d
Cleared
Dec 11, 2015
Panther StereoSeed
MUJ
System, Planning, Radiation Therapy Treatment
365d
Cleared
Dec 10, 2015
PAPAYA 3D Plus
OAS
X-ray, Tomography, Computed, Dental
302d
Cleared
Dec 09, 2015
Touch Ultrasound
IYN
System, Imaging, Pulsed Doppler, Ultrasonic
100d
Cleared
Dec 04, 2015
kVue Encompass SRS Insert (Encompass Insert), Encompass SRS Standalone (Encompass Device), Encompass SRS MRI Immobilization device (Encompass MRI Device, Encompass Intracranial Fibreplast Variable Perf Head Only Open View System, Encompass Intracranial Fibreplast Variable Perf Head Only Open View with 119 mm opening
IYE
Accelerator, Linear, Medical
109d
Cleared
Dec 04, 2015
Implant Studio 2015
LLZ
System, Image Processing, Radiological
130d
Cleared
Dec 03, 2015
Portable X-ray System (Model: MINIX-V / MINIX-S)
EHD
Unit, X-ray, Extraoral With Timer
64d
Cleared
Nov 27, 2015
Aquilion ONE Vision with FIRST 1.0 (CCRS-001A)
JAK
System, X-ray, Tomography, Computed
158d
Cleared
Nov 25, 2015
Carestream DRX-1 System with DRX Plus 4343 Detectors
MQB
Solid State X-ray Imager (flat Panel/digital Imager)
26d
Cleared
Nov 25, 2015
VidiStar HeartView
LLZ
System, Image Processing, Radiological
58d
Cleared
Nov 25, 2015
XIDF-AWS801, Angio Workstation, V6.20
OWB
Interventional Fluoroscopic X-ray System
61d
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