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
12920 Radiology devices
Cleared
Feb 14, 1992
SHIMADZU WHOLE BODY X-RAY CT SCANNER SCT-4500TE
JAK
System, X-ray, Tomography, Computed
60d
Cleared
Feb 12, 1992
KODAK X-OMATIC IDENT. CAMERA MAMMOGRAPHY UPGRADE
JAC
System, X-ray, Film Marking, Radiographic
40d
Cleared
Feb 04, 1992
DXS DIGITAL X-RAY SUBTRACTION
IZI
System, X-ray, Angiographic
126d
Cleared
Feb 04, 1992
AVIVA MAMMOGRAPHIC X-RAY SYSTEM
IZH
System, X-ray, Mammographic
43d
Cleared
Feb 03, 1992
MODIF TOP DRIVE BOARD CXT-90 90/90 DIAG TILT TABLE
IXR
Table, Radiographic, Tilting
210d
Cleared
Jan 31, 1992
SPECIAL PURPOSE COILS FOR GYREX V
LNH
System, Nuclear Magnetic Resonance Imaging
49d
Cleared
Jan 29, 1992
PSF-50ET
ITX
Transducer, Ultrasonic, Diagnostic
336d
Cleared
Jan 24, 1992
TANGENT V
IXR
Table, Radiographic, Tilting
28d
Cleared
Jan 23, 1992
CT SYTEC 8000
JAK
System, X-ray, Tomography, Computed
170d
Cleared
Jan 23, 1992
VECTRA MAGNETIC RESONANCE SYSTEM
LNH
System, Nuclear Magnetic Resonance Imaging
157d
Cleared
Jan 23, 1992
STORZ IMAGING SYSTEM
IZI
System, X-ray, Angiographic
65d
Cleared
Jan 23, 1992
MAGNETIC RESONANE DIAGNOSTIC DEVICE ACCESSORY
LNH
System, Nuclear Magnetic Resonance Imaging
55d
Cleared
Jan 13, 1992
PEGASUS LATERAL CARDIAC POSITIONER
JAA
System, X-ray, Fluoroscopic, Image-intensified
31d
Cleared
Jan 09, 1992
CARDIOMETRICS FLOWIRE/FLOMAP DOPPLER ULTRASOUND
ITX
Transducer, Ultrasonic, Diagnostic
199d
Cleared
Jan 09, 1992
PHILIPS PCR-ACE SYSTEM
LLZ
System, Image Processing, Radiological
48d
Cleared
Jan 06, 1992
SENOGRAPHE DMR/SMR/DM
IZH
System, X-ray, Mammographic
159d
Cleared
Jan 06, 1992
KODAK X-OMAT 480 RA PROCESSOR
IXW
Processor, Radiographic-film, Automatic
112d
Cleared
Dec 27, 1991
ADVANTAGE V.S. CT/MR RAD DIAGNOSTIC WORKSTATION
LNH
System, Nuclear Magnetic Resonance Imaging
127d
Cleared
Dec 27, 1991
MAGNETOM 42 SP,63 SP,IMPACT
LNH
System, Nuclear Magnetic Resonance Imaging
44d
Cleared
Dec 20, 1991
PHILIPS MAMMODIAGNOST BC
IZH
System, X-ray, Mammographic
114d
Cleared
Dec 19, 1991
KODAK EKTASCAN 1120 LASER PRINTER
LMC
Camera, Multi Format, Radiological
64d
Cleared
Dec 19, 1991
CAT-250B
IZZ
Table, Radiographic, Non-tilting, Powered
15d
Cleared
Dec 18, 1991
DOPPLER UPGRADE FOR AUSONICS OPUS 1 REAL TIME SCAN
LMB
Device, Digital Image Storage, Radiological
376d
Cleared
Dec 18, 1991
EAGLE SYSTEM
LMC
Camera, Multi Format, Radiological
176d
Cleared
Dec 17, 1991
SMARTNEEDLE(TM) VASCULAR ACCESS SYSTEM
ITX
Transducer, Ultrasonic, Diagnostic
118d
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