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
12917 Radiology devices
Cleared
Apr 27, 1992
KODAK X-OMAT FIXER MANAGER
IXW
Processor, Radiographic-film, Automatic
69d
Cleared
Apr 27, 1992
HIGH SPEED ROTATION STARTER SA-40
ITY
Assembly, Tube Housing, X-ray, Diagnostic
69d
Cleared
Apr 27, 1992
HIGH SPEED ROTATION STARTER SA-50
ITY
Assembly, Tube Housing, X-ray, Diagnostic
69d
Cleared
Apr 27, 1992
BUCKY TABLE BK-12
IXQ
Table, Radiographic, Stationary Top
69d
Cleared
Apr 27, 1992
X-RAY HIGH VOLTAGE GENERATOR ED 125L
IZO
Generator, High-voltage, X-ray, Diagnostic
69d
Cleared
Apr 27, 1992
HYDRAJUST IV UROLOGICAL TABLE
IXR
Table, Radiographic, Tilting
68d
Cleared
Apr 27, 1992
PHILIPS EASYVISION
LLZ
System, Image Processing, Radiological
61d
Cleared
Apr 27, 1992
SONO-VU US(TM), MODIFICATION
HIO
Sampler, Amniotic Fluid (amniocentesis Tray)
89d
Cleared
Apr 21, 1992
FETAL DOPPLER
MAA
Monitor, Fetal Doppler Ultrasound
497d
Cleared
Apr 20, 1992
DIGITAL RADIOGRAPHY SYSTEM IDR-1000
JAA
System, X-ray, Fluoroscopic, Image-intensified
62d
Cleared
Apr 16, 1992
OPTIMA NUCLEAR TOMOGRAPHY STYSTEM
KPS
System, Tomography, Computed, Emission
132d
Cleared
Apr 16, 1992
COLLIMATOR F-20
IZW
Collimator, Automatic, Radiographic
58d
Cleared
Apr 16, 1992
CEILING TUBE SUPPORT CH-30X
IYB
Tube Mount, X-ray, Diagnostic
58d
Cleared
Apr 16, 1992
CATHERIZATION KS-50
IZZ
Table, Radiographic, Non-tilting, Powered
58d
Cleared
Apr 16, 1992
STEREO COLLIMATOR RF-T SERIES
IZW
Collimator, Automatic, Radiographic
58d
Cleared
Apr 15, 1992
DIGITAL RADIOGRAPHY SYSTEM IDR-2000
JAA
System, X-ray, Fluoroscopic, Image-intensified
57d
Cleared
Apr 14, 1992
INSTRUMENTARIUM MEGA4 HT
LNH
System, Nuclear Magnetic Resonance Imaging
89d
Cleared
Apr 14, 1992
CIRCLEXO.3T X-RAY TUBE ASSEMBLY
ITY
Assembly, Tube Housing, X-ray, Diagnostic
75d
Cleared
Apr 13, 1992
OR340 INTRAOPERATIVE ULTRASOUND BIOPSY NEEDLE GUID
ITY
Assembly, Tube Housing, X-ray, Diagnostic
221d
Cleared
Apr 13, 1992
X-RAY DIAGNOSTIC TABLE YSF-200-30-90
IXR
Table, Radiographic, Tilting
55d
Cleared
Apr 06, 1992
MRT-50 FLEXIBLE BODY COIL
LNH
System, Nuclear Magnetic Resonance Imaging
87d
Cleared
Apr 06, 1992
MU125M MOBILE X-RAY SYSTEM
IZG
System, X-ray, Photofluorographic
67d
Cleared
Apr 02, 1992
SACA, 3.5 MHZ PROBE
ITX
Transducer, Ultrasonic, Diagnostic
499d
Cleared
Apr 02, 1992
BIPLANE TRANSRECTAL PROBE
ITX
Transducer, Ultrasonic, Diagnostic
206d
Cleared
Apr 02, 1992
ALOKA 650CL DIAGNOSTIC ULTRASOUND SYSTEM
IYO
System, Imaging, Pulsed Echo, Ultrasonic
64d
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