FDA 510(k) Radiology Devices
About Radiology Devices
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
15452
Total
15433
Cleared
107d
Avg days
1976
Since
1587 Radiology devices
Cleared
May 30, 2023
KBA3D
LLZ
System, Image Processing, Radiological
159d
Cleared
May 26, 2023
Eclipse Treatment Planning System (v18.0)
MUJ
System, Planning, Radiation Therapy Treatment
87d
Cleared
May 25, 2023
Critical Care Suite with Pneumothorax Detection AI Algorithm, Critical Care Suite 2.1, Critical Care Suite
QBS
Radiological Computer Assisted Detection/diagnosis Software For Fracture
185d
Cleared
May 23, 2023
ROSA Hip System
LLZ
System, Image Processing, Radiological
29d
Cleared
May 23, 2023
uMR Omega
LNH
System, Nuclear Magnetic Resonance Imaging
124d
Cleared
May 23, 2023
Genius AI Detection 2.0 with CC-MLO Correlation
QDQ
Radiological Computer Assisted Detection/diagnosis Software For Lesions Suspicious For Cancer
130d
Cleared
May 22, 2023
TrueBeam, TrueBeam STx, Edge, VitalBeam
IYE
Accelerator, Linear, Medical
151d
Cleared
May 18, 2023
uMR 570
LNH
System, Nuclear Magnetic Resonance Imaging
59d
Cleared
May 18, 2023
C510G/JUSHA-C510G/C510/JUSHA- C510 LCD Monitor
PGY
Display, Diagnostic Radiology
63d
Cleared
May 17, 2023
Symbia Pro.specta VA20A Family
KPS
System, Tomography, Computed, Emission
29d
Cleared
May 12, 2023
EPIQ Series Diagnostic Ultrasound System
IYN
System, Imaging, Pulsed Doppler, Ultrasonic
16d
Cleared
May 12, 2023
RadiForce MX217
PGY
Display, Diagnostic Radiology
60d
Cleared
May 11, 2023
ExacTrac Dynamic 1.1.2
IYE
Accelerator, Linear, Medical
28d
Cleared
May 11, 2023
SubtleMR (2.3.x)
LLZ
System, Image Processing, Radiological
157d
Cleared
May 09, 2023
CX50N
PGY
Display, Diagnostic Radiology
243d
Cleared
May 08, 2023
MX50N
PGY
Display, Diagnostic Radiology
242d
Cleared
May 04, 2023
Auto Segmentation
QKB
Radiological Image Processing Software For Radiation Therapy
113d
Cleared
May 01, 2023
CP620G LCD monitor, CP620 LCD monitor
PGY
Display, Diagnostic Radiology
54d
Cleared
Apr 28, 2023
Ingenia Elition and MR 7700 MR Systems
LNH
System, Nuclear Magnetic Resonance Imaging
23d
Cleared
Apr 28, 2023
VERITON CT 300 Series Digital SPECT/CT System (VERITON CT 316/364)
KPS
System, Tomography, Computed, Emission
56d
Cleared
Apr 27, 2023
32HL512D, 31HN713D, 32HQ713D
PGY
Display, Diagnostic Radiology
30d
Cleared
Apr 27, 2023
Precision DL
KPS
System, Tomography, Computed, Emission
192d
Cleared
Apr 26, 2023
MR DWI/FLAIR Measurement V1.0
LLZ
System, Image Processing, Radiological
57d
Cleared
Apr 25, 2023
Konicaminolta DI-X1
LLZ
System, Image Processing, Radiological
25d
Cleared
Apr 21, 2023
EzDent Web
LLZ
System, Image Processing, Radiological
59d
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