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
Jun 10, 1992
SHIMADZU IMAGE AMPLIFIER IA-12VMA SERIES
JAA
System, X-ray, Fluoroscopic, Image-intensified
42d
Cleared
Jun 09, 1992
ACCESS QD HEAD COIL
LNH
System, Nuclear Magnetic Resonance Imaging
153d
Cleared
May 29, 1992
UROLOGICAL X-RAY TABLE HS-10A
IXR
Table, Radiographic, Tilting
101d
Cleared
May 29, 1992
X-RAY TUBE ASSEMBLY CIRCLEX1.2UG
ITY
Assembly, Tube Housing, X-ray, Diagnostic
101d
Cleared
May 29, 1992
SONOS 100 ULTRASOUND IMAGING SYSTEM
ITX
Transducer, Ultrasonic, Diagnostic
86d
Cleared
May 28, 1992
ULTRA-VISION RAPID INTENSIFYING SCREEN
EAM
Screen, Intensifying, Radiographic
134d
Cleared
May 28, 1992
ULTRA-VISION DETAIL INTENSIFYING SCREEN
EAM
Screen, Intensifying, Radiographic
134d
Cleared
May 28, 1992
X-RAY DIAGNOSTIC TABLE YSF-100
IXR
Table, Radiographic, Tilting
100d
Cleared
May 28, 1992
BO POWER SUPPLY
LNH
System, Nuclear Magnetic Resonance Imaging
85d
Cleared
May 28, 1992
ADAC S315
IYX
Camera, Scintillation (gamma)
72d
Cleared
May 28, 1992
SHIMADZU WHOLE BODY X-RAY CT SCANNER SCT-4500TF
JAK
System, X-ray, Tomography, Computed
64d
Cleared
May 27, 1992
ULTRA-VISION FAST DETAIL INTENSIFYING SCREEN
EAM
Screen, Intensifying, Radiographic
133d
Cleared
May 27, 1992
3M DIGITAL DISK INTERFACE UNIT
LMD
System, Digital Image Communications, Radiological
127d
Cleared
May 22, 1992
PRESATURATION
LNH
System, Nuclear Magnetic Resonance Imaging
88d
Cleared
May 19, 1992
AUSONICS OPUS 1 SYSTEM, ANNULAR ARRAY OPTION
ITX
Transducer, Ultrasonic, Diagnostic
117d
Cleared
May 18, 1992
PHILIPS BV26 MOBILE C-ARM STAND
OXO
Image-intensified Fluoroscopic X-ray System, Mobile
63d
Cleared
May 15, 1992
ACCESSORY TO GENESIS III (GCFM)
DXK
Echocardiograph
301d
Cleared
May 15, 1992
MAGNETIC RESONANCE DIAGNOSTIC DEVICE ACCESSORIES
LNH
System, Nuclear Magnetic Resonance Imaging
128d
Cleared
May 15, 1992
MAGNETOM 63SP
LNH
System, Nuclear Magnetic Resonance Imaging
67d
Cleared
May 15, 1992
PHILIPS INTEGRIS V3000 FILM
IZI
System, X-ray, Angiographic
67d
Cleared
May 15, 1992
DELUXE C ARM RADIOLOGICAL TABLE, MODEL #056-004
IZZ
Table, Radiographic, Non-tilting, Powered
45d
Cleared
May 01, 1992
KODAK X-OMAT MODEL 180 LP PROCESSOR
IXW
Processor, Radiographic-film, Automatic
45d
Cleared
Apr 28, 1992
MRT-50 MULTIVIEW COIL
LNH
System, Nuclear Magnetic Resonance Imaging
111d
Cleared
Apr 27, 1992
ECAT EXACT HR MODEL 961
KPS
System, Tomography, Computed, Emission
76d
Cleared
Apr 27, 1992
POLYTRON DIGITAL IMAGING SYSTEM
IZI
System, X-ray, Angiographic
69d
Looking for a specific radiology device? Search by device name, K-number or manufacturer.
Search all Radiology 510(k) devices