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
4767 Radiology devices
Cleared
May 29, 1997
SONOLINE VERSA 555 DIAGNOSTIC ULTRASOUND SYSTEM
IYO
System, Imaging, Pulsed Echo, Ultrasonic
360d
Cleared
May 14, 1997
MULTIX TOP/PRO RADIOGRAPHIC X-RAY TABLE
IZZ
Table, Radiographic, Non-tilting, Powered
23d
Cleared
May 08, 1997
DSBAS OPTION THE MAMMOMAT 3000 MAMMOGRAPHY X-RAY SYSTEM
IZH
System, X-ray, Mammographic
210d
Cleared
Apr 25, 1997
SATURNE MULTILEAF COLLIMATOR
IXI
Block, Beam-shaping, Radiation Therapy
88d
Cleared
Apr 24, 1997
SONOLINE VERSA PRO DIAGNOSTIC ULTRASOUND SYSTEM
IYO
System, Imaging, Pulsed Echo, Ultrasonic
274d
Cleared
Apr 22, 1997
SONOS 2000, SONOS 2500 (M2406 A)
IYN
System, Imaging, Pulsed Doppler, Ultrasonic
175d
Cleared
Apr 21, 1997
SIREGRAGH T.O.P. 33 AND SIREGRAPH T.O.P. 40 UNIVERSAL FLUOROSCOPIC X-RAY SYSTEMS
OWB
Interventional Fluoroscopic X-ray System
52d
Cleared
Apr 04, 1997
KODAK EKTASIAN HG FILM (EHG-15)
IWZ
Film, Radiographic
78d
Cleared
Apr 03, 1997
CLINICAL PHOSPHORUS SPECTROSCOPY OPTION/MAGNETOM VISION SYSTEM
LNI
System, Nuclear Magnetic Resonance Spectroscopic
272d
Cleared
Mar 21, 1997
EPI-SCOPE OPTION FOR Q SERIES CT SYSTEMS
LLZ
System, Image Processing, Radiological
302d
Cleared
Mar 19, 1997
PHILIPS SONO DIAGNOST 800
IYO
System, Imaging, Pulsed Echo, Ultrasonic
184d
Cleared
Mar 17, 1997
SD 800 SONODIAGNOST ULTRASOUND IMAGING SYSTEM
ITX
Transducer, Ultrasonic, Diagnostic
73d
Cleared
Mar 11, 1997
C.A.R.E. VISION FOR THE SOMATOM PLUS 4 CT SCANNER
JAK
System, X-ray, Tomography, Computed
85d
Cleared
Feb 26, 1997
UHE COLLIMATOR (210591)
KPS
System, Tomography, Computed, Emission
181d
Cleared
Feb 24, 1997
KINEMATIC POSITIONING DEVICES
LNH
System, Nuclear Magnetic Resonance Imaging
89d
Cleared
Feb 21, 1997
PRISM XPVT SYSTEM (210823)
KPS
System, Tomography, Computed, Emission
88d
Cleared
Feb 11, 1997
PHASED ARRAY NECK COIL
MOS
Coil, Magnetic Resonance, Specialty
82d
Cleared
Feb 10, 1997
SOMATOM PLUS 4 CT SCANNER
JAK
System, X-ray, Tomography, Computed
76d
Cleared
Feb 10, 1997
EDGE/VISTA SYSTEM ENHANCEMENT PACKAGE
LNH
System, Nuclear Magnetic Resonance Imaging
83d
Cleared
Jan 27, 1997
KODAK MINILOADER(2000)
IXW
Processor, Radiographic-film, Automatic
20d
Cleared
Jan 17, 1997
MAGNETIC RESONANCE DIAGNOSTIC ACCESSORY
LNH
System, Nuclear Magnetic Resonance Imaging
80d
Cleared
Dec 23, 1996
ORTHORALIX E/GX-9000 PANORAMIC X-RAY SYSTEM
EHD
Unit, X-ray, Extraoral With Timer
33d
Cleared
Nov 29, 1996
SIMVIEW 3000 CT OPTION
KPQ
System, Simulation, Radiation Therapy
508d
Cleared
Nov 22, 1996
PHASED ARRAY SHOULDER COIL
MOS
Coil, Magnetic Resonance, Specialty
88d
Cleared
Oct 29, 1996
HELAX TMS BRACHYTHERAPY, VERSION 3.0
LNH
System, Nuclear Magnetic Resonance Imaging
97d
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