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
4605 Radiology devices
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
Cleared
Apr 14, 2020
JiveX
LLZ
System, Image Processing, Radiological
27d
Cleared
Apr 14, 2020
Xelis Dental 2.0
LLZ
System, Image Processing, Radiological
131d
Cleared
Apr 13, 2020
AcuityPDR
IZL
System, X-ray, Mobile
24d
Cleared
Apr 13, 2020
CuraRad-ICH
QAS
Radiological Computer-assisted Triage And Notification Software
248d
Cleared
Apr 10, 2020
DR-ID 1200SDK System
MQB
Solid State X-ray Imager (flat Panel/digital Imager)
28d
Cleared
Apr 10, 2020
ACUSON Freestyle Diagnostic Ultrasound System
IYN
System, Imaging, Pulsed Doppler, Ultrasonic
30d
Cleared
Apr 10, 2020
VARO Plan
LLZ
System, Image Processing, Radiological
87d
Cleared
Apr 10, 2020
SIGNA Premier
LNH
System, Nuclear Magnetic Resonance Imaging
135d
Cleared
Apr 10, 2020
Achieva, Intera, Ingenia, Ingneia CX, Ingenia Elition, and Ingenia Ambition MR Systems
LNH
System, Nuclear Magnetic Resonance Imaging
141d
Cleared
Apr 09, 2020
EchoNavigator
LLZ
System, Image Processing, Radiological
22d
Cleared
Apr 09, 2020
hyperion X5, NewTom GO, X-RADiUS COMPACT
OAS
X-ray, Tomography, Computed, Dental
24d
Cleared
Apr 09, 2020
MX7/ MX7T/ Vaus7/ Zeus Diagnostic Ultrasound System, ME7/ Anesus ME7/ Anesus ME7T Diagnostic Ultrasound System, MX8/ MX8T/ Vaus8/ ME8 Diagnostic Ultrasound System
IYN
System, Imaging, Pulsed Doppler, Ultrasonic
98d
Cleared
Apr 09, 2020
ClearCalc
MUJ
System, Planning, Radiation Therapy Treatment
104d
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