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
15507
Total
15488
Cleared
146d
Avg (2y)
1976
Since
4789 Radiology devices
Cleared
Sep 11, 1992
KODAK EKTASCAN IMAGELINK QUALITY CONTROL WORKSTATI
LLZ
System, Image Processing, Radiological
67d
Cleared
Sep 11, 1992
SCAN BAND
JAK
System, X-ray, Tomography, Computed
78d
Cleared
Sep 11, 1992
DU PONT COMPACT DAYLIGHT SYSTEM 2000
KPX
Changer, Radiographic Film/cassette
107d
Cleared
Aug 28, 1992
AWOS ANGIOGRAPHIC WORKSTATION
IZI
System, X-ray, Angiographic
79d
Cleared
Aug 26, 1992
KODAK INSIGHT PORTABLE IMAGING SYSTEM
IXA
Cassette, Radiographic Film
132d
Cleared
Aug 24, 1992
KODAK EKTASCAN, XLT7720, XLT7700, PCD 2000
LMC
Camera, Multi Format, Radiological
95d
Cleared
Aug 20, 1992
VISTA HPQ SYSTEM
LNH
System, Nuclear Magnetic Resonance Imaging
184d
Cleared
Jul 30, 1992
HP SONOS 100 CF ULTRASOUND IMAGING SYSTEM
ITX
Transducer, Ultrasonic, Diagnostic
80d
Cleared
Jul 21, 1992
MPG 65-80-100 X-RAY GENERATOR AND CONTROL
IZO
Generator, High-voltage, X-ray, Diagnostic
85d
Cleared
Jul 17, 1992
VISTA HPQ SYSTEM
LNH
System, Nuclear Magnetic Resonance Imaging
88d
Cleared
Jul 01, 1992
KODAK EKTASCAN 2180 LASER PRINTER
LMC
Camera, Multi Format, Radiological
79d
Cleared
Jun 15, 1992
VISTA HP/HPQ SYSTEM
LNH
System, Nuclear Magnetic Resonance Imaging
73d
Cleared
May 29, 1992
SONOS 100 ULTRASOUND IMAGING SYSTEM
ITX
Transducer, Ultrasonic, Diagnostic
86d
Cleared
May 28, 1992
ULTRA-VISION DETAIL INTENSIFYING SCREEN
EAM
Screen, Intensifying, Radiographic
134d
Cleared
May 28, 1992
ULTRA-VISION RAPID INTENSIFYING SCREEN
EAM
Screen, Intensifying, Radiographic
134d
Cleared
May 27, 1992
3M DIGITAL DISK INTERFACE UNIT
LMD
System, Digital Image Communications, Radiological
127d
Cleared
May 27, 1992
ULTRA-VISION FAST DETAIL INTENSIFYING SCREEN
EAM
Screen, Intensifying, Radiographic
133d
Cleared
May 15, 1992
MAGNETOM 63SP
LNH
System, Nuclear Magnetic Resonance Imaging
67d
Cleared
May 15, 1992
MAGNETIC RESONANCE DIAGNOSTIC DEVICE ACCESSORIES
LNH
System, Nuclear Magnetic Resonance Imaging
128d
Cleared
May 01, 1992
KODAK X-OMAT MODEL 180 LP PROCESSOR
IXW
Processor, Radiographic-film, Automatic
45d
Cleared
Apr 27, 1992
KODAK X-OMAT FIXER MANAGER
IXW
Processor, Radiographic-film, Automatic
69d
Cleared
Apr 27, 1992
POLYTRON DIGITAL IMAGING SYSTEM
IZI
System, X-ray, Angiographic
69d
Cleared
Apr 16, 1992
OPTIMA NUCLEAR TOMOGRAPHY STYSTEM
KPS
System, Tomography, Computed, Emission
132d
Cleared
Mar 13, 1992
LAPAROSCAN(TM) INTRAOPER DIAG ULTRASOUND SYSTEM
ITX
Transducer, Ultrasonic, Diagnostic
221d
Cleared
Mar 06, 1992
HEAD COIL GEOMETRIC DISTOR SPEC FOR VISTA HPQ SYST
LNH
System, Nuclear Magnetic Resonance Imaging
51d
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