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
15620
Total
15601
Cleared
148d
Avg (2y)
1976
Since
12868 Radiology devices
Cleared
Feb 05, 1997
PLANNED SOPHIED CLASSIC
IZH
System, X-ray, Mammographic
250d
Cleared
Feb 04, 1997
PORTPRO ELECTRONIC PORTAL IMAGING SYSTEM
IYE
Accelerator, Linear, Medical
88d
Cleared
Feb 04, 1997
MRT-35A V9.0
LNH
System, Nuclear Magnetic Resonance Imaging
78d
Cleared
Jan 30, 1997
GE STERILE DISPOSABLE EQUIPMENT COIL COVER
MOS
Coil, Magnetic Resonance, Specialty
107d
Cleared
Jan 30, 1997
ELECTROPHYSIOLOGY TILT TABLE MODEL #9660
IXR
Table, Radiographic, Tilting
41d
Cleared
Jan 27, 1997
LR 5200 LASER FILM RECORDER
LMC
Camera, Multi Format, Radiological
83d
Cleared
Jan 27, 1997
PANOURA ULTRA PAN AND PANOURA ULTRA PAN/CEPH PANORAMIC/CEPHALOMETRIC X-RAY UNIT
EHD
Unit, X-ray, Extraoral With Timer
39d
Cleared
Jan 27, 1997
FLUOROVIEW SERIES FLUOROSCOPIC TABLES
IXR
Table, Radiographic, Tilting
38d
Cleared
Jan 27, 1997
KODAK MINILOADER(2000)
IXW
Processor, Radiographic-film, Automatic
20d
Cleared
Jan 24, 1997
THE ROBOLITE
JQP
Calculator/data Processing Module, For Clinical Use
78d
Cleared
Jan 24, 1997
PROFILE 70000 QUADRATURE VOLUME NECK COIL
LNH
System, Nuclear Magnetic Resonance Imaging
73d
Cleared
Jan 24, 1997
HISPEED CT/I WITH PERFORMIX TUBE AND WARP SCAN OPTION
JAK
System, X-ray, Tomography, Computed
59d
Cleared
Jan 23, 1997
PERCUPUMP II WITH EDA
DSB
Plethysmograph, Impedance
255d
Cleared
Jan 23, 1997
TILTING RADIOGRAPHIC TABLE (REMOTE)
IXR
Table, Radiographic, Tilting
120d
Cleared
Jan 22, 1997
DIASONICS ITNRAOPERATIVE PROBES
ITX
Transducer, Ultrasonic, Diagnostic
316d
Cleared
Jan 21, 1997
NEUROGUARD TRANSCRANIAL DOPPLER ULTRASOUND SYSTEM
IYN
System, Imaging, Pulsed Doppler, Ultrasonic
187d
Cleared
Jan 17, 1997
DIGITAL IMAGE ANALYSIS SYSTEM
LLZ
System, Image Processing, Radiological
227d
Cleared
Jan 17, 1997
MAGNETIC RESONANCE DIAGNOSTIC ACCESSORY
LNH
System, Nuclear Magnetic Resonance Imaging
80d
Cleared
Jan 17, 1997
IPU RX-2
LLZ
System, Image Processing, Radiological
79d
Cleared
Jan 17, 1997
XRT-7.0
JAK
System, X-ray, Tomography, Computed
63d
Cleared
Jan 17, 1997
DIGISCOPE RX-2 (9 OPTION)
OXO
Image-intensified Fluoroscopic X-ray System, Mobile
32d
Cleared
Jan 10, 1997
VOLMETRIC COINCIDENCE DETECTION SYSTEM
KPS
System, Tomography, Computed, Emission
225d
Cleared
Jan 10, 1997
PIXELL MRI SYSTEM
LNH
System, Nuclear Magnetic Resonance Imaging
213d
Cleared
Jan 10, 1997
VARIAN XIMATRON C-SERIES RADIATION THERAPY SIMULATOR WITH VERSION 4.2 SOFTWARE
KPQ
System, Simulation, Radiation Therapy
87d
Cleared
Jan 10, 1997
WRITESTAR, AND VIEWSTAR
LMB
Device, Digital Image Storage, Radiological
77d
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