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
1608 Radiology devices
Cleared
Jan 25, 2021
vatech A9 (Model : PHT-30CSS)
OAS
X-ray, Tomography, Computed, Dental
28d
Cleared
Jan 25, 2021
Diagnostic Ultrasound System, Models: Acclarix AX3, Acclarix AX3 Exp, Acclarix AX3 Super, Acclarix AX25, Acclarix AX28, Acclarix AX2, Acclarix AX2 Exp, Acclarix AX2 Super, Acclarix AX15, Acclarix AX18, Acclarix LX3, Acclarix LX3 Exp, Acclarix LX3 Super, Acclarix LX25 and Acclarix LX28
IYN
System, Imaging, Pulsed Doppler, Ultrasonic
119d
Cleared
Jan 15, 2021
Vantage Orian 1.5T, MRT-1550, V6.0
LNH
System, Nuclear Magnetic Resonance Imaging
116d
Cleared
Jan 14, 2021
Mobius3D
IYE
Accelerator, Linear, Medical
29d
Cleared
Jan 12, 2021
Aquilion Lightning (TSX-036A/7) V10.2 with AiCE-i
JAK
System, X-ray, Tomography, Computed
194d
Cleared
Jan 08, 2021
LOGIQ P10, LOGIQ P9, LOGIQ P8
IYN
System, Imaging, Pulsed Doppler, Ultrasonic
85d
Cleared
Jan 07, 2021
MULTIX Impact
KPR
System, X-ray, Stationary
55d
Cleared
Jan 06, 2021
MULTIX Impact C
KPR
System, X-ray, Stationary
55d
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