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
12904 Radiology devices
Cleared
Dec 04, 1992
MTV-250A, MTV-300A
LMA
Digitizer, Image, Radiological
92d
Cleared
Dec 03, 1992
CEREBROVASCULAR DIAGNOSTIC SYSTEM
IYN
System, Imaging, Pulsed Doppler, Ultrasonic
401d
Cleared
Dec 03, 1992
CONVEX AND LINEAR ARRAY TRANSDUCERS
IYO
System, Imaging, Pulsed Echo, Ultrasonic
150d
Cleared
Dec 03, 1992
MAXXUS
KPS
System, Tomography, Computed, Emission
90d
Cleared
Dec 03, 1992
SHIMADZU RADIOGRAPJHIC STAND BR-100
KPX
Changer, Radiographic Film/cassette
51d
Cleared
Dec 02, 1992
ANGIOGRAPHIC X-RAY SYSTEM
IZI
System, X-ray, Angiographic
204d
Cleared
Nov 27, 1992
ACUSON V714OR TRANSDUCER
ITX
Transducer, Ultrasonic, Diagnostic
252d
Cleared
Nov 27, 1992
UROLOGICAL C-ARM TABLE, MODEL #056-450
IXR
Table, Radiographic, Tilting
178d
Cleared
Nov 27, 1992
SIGNA BREAST COIL AND ARRAY ACCESSORY
LNH
System, Nuclear Magnetic Resonance Imaging
157d
Cleared
Nov 27, 1992
BODY BAND RESTRAINT STRAP SET
JAA
System, X-ray, Fluoroscopic, Image-intensified
155d
Cleared
Nov 27, 1992
KODAK X-OMAT FS-1A PROCESSOR
IXW
Processor, Radiographic-film, Automatic
133d
Cleared
Nov 27, 1992
RADIOGRAPHIC FILM MARKETING SYSTEM
JAC
System, X-ray, Film Marking, Radiographic
92d
Cleared
Nov 27, 1992
GENERAL PURPOSE FLEX COIL, CATALOG NUMBER M1685GP
LNH
System, Nuclear Magnetic Resonance Imaging
92d
Cleared
Nov 27, 1992
SHIMADZU RADIOGRAPHIC TABLE BK-100
IZZ
Table, Radiographic, Non-tilting, Powered
45d
Cleared
Nov 27, 1992
SHIMADZU X-RAY DIAGNOSTIC TABLE YSF-200 30/90
IXR
Table, Radiographic, Tilting
45d
Cleared
Nov 24, 1992
INTERSPEC APOGEE ENDO-V PROBE AND NEEDLE GUIDE
ITX
Transducer, Ultrasonic, Diagnostic
337d
Cleared
Nov 24, 1992
PLANMED CYTOGUIDE
IZH
System, X-ray, Mammographic
133d
Cleared
Nov 24, 1992
DIAGNOST 76 FAMILY*R/F SYSTEMS - RELEASE 4.4
IXL
Device, Spot-film
75d
Cleared
Nov 23, 1992
KINEMATIC MRI MOVIEMAKER
LNH
System, Nuclear Magnetic Resonance Imaging
97d
Cleared
Nov 20, 1992
POLY DIAGNOST CDX
IZI
System, X-ray, Angiographic
122d
Cleared
Nov 10, 1992
MRT-35(TM)
LNH
System, Nuclear Magnetic Resonance Imaging
200d
Cleared
Nov 09, 1992
SONICATH(TM) 3.5 F, 20 MHZ
ITX
Transducer, Ultrasonic, Diagnostic
438d
Cleared
Nov 09, 1992
SIGNA ADVANTAGE 0.5T MAG RESON SYS-FAST ACQUIS OPT
LNH
System, Nuclear Magnetic Resonance Imaging
199d
Cleared
Nov 09, 1992
DU PONT LINX HD-25 LASR IMAGER
LLZ
System, Image Processing, Radiological
138d
Cleared
Nov 06, 1992
PHILIPS GYROSCAN T5 SERIES II
LNH
System, Nuclear Magnetic Resonance Imaging
270d
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