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
147d
Avg (2y)
1976
Since
12372 Radiology devices
Cleared
May 07, 2020
EZER, Portable X-ray System
IZL
System, X-ray, Mobile
139d
Cleared
May 06, 2020
Accuvue+
MQB
Solid State X-ray Imager (flat Panel/digital Imager)
15d
Cleared
May 05, 2020
ZeeroMED View
LLZ
System, Image Processing, Radiological
63d
Cleared
May 05, 2020
Ziostation2
LLZ
System, Image Processing, Radiological
88d
Cleared
May 05, 2020
AVIEW LCS
LLZ
System, Image Processing, Radiological
166d
Cleared
May 05, 2020
uMR 780
LNH
System, Nuclear Magnetic Resonance Imaging
169d
Cleared
May 01, 2020
EPIQ Diagnostic Ultrasound System Series, Affiniti Diagnostic Ultrasound System Series, CX50 Diagnostic Ultrasound System, Sparq Diagnostic Ultrasound System, Lumify Diagnostic Ultrasound System
IYN
System, Imaging, Pulsed Doppler, Ultrasonic
14d
Cleared
May 01, 2020
Wireless Digital Flat Panel Detector Model Name Mars1417V-TSI, Wireless Digital Flat Panel Detector Model Name Mano4336W
MQB
Solid State X-ray Imager (flat Panel/digital Imager)
15d
Cleared
May 01, 2020
Azurion R2.1
OWB
Interventional Fluoroscopic X-ray System
25d
Cleared
May 01, 2020
Optimized Positioning System (OPS) Insight
LLZ
System, Image Processing, Radiological
219d
Cleared
May 01, 2020
Image Guidance System for Radiotherapy
IYE
Accelerator, Linear, Medical
241d
Cleared
Apr 29, 2020
Evry
LNH
System, Nuclear Magnetic Resonance Imaging
79d
Cleared
Apr 27, 2020
Panther Stereotactic
MUJ
System, Planning, Radiation Therapy Treatment
133d
Cleared
Apr 24, 2020
O-arm O2 Imaging System
OWB
Interventional Fluoroscopic X-ray System
101d
Cleared
Apr 23, 2020
BSD3543W
MQB
Solid State X-ray Imager (flat Panel/digital Imager)
28d
Cleared
Apr 22, 2020
Acuson SC2000 Diagnostic Ultrasound System
IYN
System, Imaging, Pulsed Doppler, Ultrasonic
47d
Cleared
Apr 21, 2020
NinesAI
QAS
Radiological Computer-assisted Triage And Notification Software
140d
Cleared
Apr 20, 2020
Sentinel
IYE
Accelerator, Linear, Medical
42d
Cleared
Apr 20, 2020
uMR 570
LNH
System, Nuclear Magnetic Resonance Imaging
105d
Cleared
Apr 17, 2020
LOGIQ E10
IYN
System, Imaging, Pulsed Doppler, Ultrasonic
86d
Cleared
Apr 16, 2020
Caption Guidance
QJU
Image Acquisition And/or Optimization Guided By Artificial Intelligence
24d
Cleared
Apr 16, 2020
ARTIS Icono
OWB
Interventional Fluoroscopic X-ray System
136d
Cleared
Apr 15, 2020
AS-10
OWB
Interventional Fluoroscopic X-ray System
13d
Cleared
Apr 15, 2020
ACUSON Sequoia Diagnostic Ultrasound System
IYN
System, Imaging, Pulsed Doppler, Ultrasonic
28d
Cleared
Apr 15, 2020
I-View Gold and Imagen Gold Dental Sensors
MUH
System, X-ray, Extraoral Source, Digital
36d
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