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
15668
Total
15649
Cleared
148d
Avg (2y)
1976
Since
12959 Radiology devices
Cleared
Dec 31, 1985
DIASONICS ADA400 ADVANCED DIGITAL ARRAY
IYO
System, Imaging, Pulsed Echo, Ultrasonic
238d
Cleared
Dec 23, 1985
HEWLETT PACKARD ULTRASOUND TRANSDUCER 21230A
IYO
System, Imaging, Pulsed Echo, Ultrasonic
74d
Cleared
Dec 09, 1985
RT3600(115V) RT3600(220/240V)
ITX
Transducer, Ultrasonic, Diagnostic
130d
Cleared
Dec 05, 1985
COMPUTERIZED RADIATION TREATMENT PLANNING SYS
LHN
System, Radiation Therapy, Charged-particle, Medical
80d
Cleared
Dec 02, 1985
SONOLAYER-L, SAL-77A
ITX
Transducer, Ultrasonic, Diagnostic
203d
Cleared
Nov 29, 1985
EDEC 2000
IZO
Generator, High-voltage, X-ray, Diagnostic
143d
Cleared
Nov 26, 1985
KEY MED TRANSENDOSCOPIC VASCULAR DETECTOR TVD-1
JAF
Monitor, Ultrasonic, Nonfetal
250d
Cleared
Nov 26, 1985
ACOUSTICALLY-COUPLED ELECTRONIC PHANTOM 84-410
ITX
Transducer, Ultrasonic, Diagnostic
78d
Cleared
Nov 19, 1985
JUMBO DIGITAL GAMMACAMERA GCA-90B WI & W2
IYX
Camera, Scintillation (gamma)
92d
Cleared
Nov 15, 1985
TECHNICARE 720 HPS CT SCANNER
JAK
System, X-ray, Tomography, Computed
18d
Cleared
Nov 13, 1985
LINEAR ARRAY PROBE PLB-310M FOR SAL-32B
IYO
System, Imaging, Pulsed Echo, Ultrasonic
98d
Cleared
Nov 08, 1985
TOSHIBA TCT-900S COMPUTED TOMOGRAPHY CT X-RAY SYS
JAK
System, X-ray, Tomography, Computed
84d
Cleared
Nov 07, 1985
MEDIPART DRIERITE MP-1002
IYT
System, Rebreathing, Radionuclide
73d
Cleared
Nov 07, 1985
MEDIPART DISPOS. XENON 133 ADMIN. SET MP-0133M
IYT
System, Rebreathing, Radionuclide
73d
Cleared
Nov 07, 1985
MEDIPART DISPOS. XENON 133 ADMIN. SYS MP-0133
IYT
System, Rebreathing, Radionuclide
73d
Cleared
Oct 31, 1985
SDL-32 ELECTRONIC LINEAR SCANNER
IYO
System, Imaging, Pulsed Echo, Ultrasonic
244d
Cleared
Oct 31, 1985
UNIVERSAL SERVICE MODULE
IYO
System, Imaging, Pulsed Echo, Ultrasonic
203d
Cleared
Oct 31, 1985
DIASONICS DRF-200 ULTRASOUND IMAGING SYSTEM
IYO
System, Imaging, Pulsed Echo, Ultrasonic
188d
Cleared
Oct 31, 1985
UROLOGICAL ULTRASOUND DIAGNOSTIC SYS/EQUIP. SSD-52
IYO
System, Imaging, Pulsed Echo, Ultrasonic
149d
Cleared
Oct 29, 1985
DYNAMIC CARDIAC PHANTOM 74-347
IXY
Holder, Radiographic Cassette, Wall-mounted
50d
Cleared
Oct 28, 1985
MEVAPLAN AND SOMADOS
KPQ
System, Simulation, Radiation Therapy
144d
Cleared
Oct 28, 1985
VARIAN XIMATRON C-SERIES RADIOTHERAPY TREATMENT ST
KPQ
System, Simulation, Radiation Therapy
77d
Cleared
Oct 28, 1985
UNIVERSAL STAND FOR FILM CHANGER
KPX
Changer, Radiographic Film/cassette
34d
Cleared
Oct 28, 1985
OMNI PLANE SYSTEM
IXR
Table, Radiographic, Tilting
21d
Cleared
Oct 24, 1985
ACUSON RADIOLOGY DOPPLER ACCESSORY
ITX
Transducer, Ultrasonic, Diagnostic
101d
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