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
Jan 10, 1997
PHILIPS TOMOSCAN AV EXPANDER UPGRADE
JAK
System, X-ray, Tomography, Computed
73d
Cleared
Jan 10, 1997
MAGNETIC RESONANCE DIAGNOSTIC SYSTEM
LNH
System, Nuclear Magnetic Resonance Imaging
70d
Cleared
Jan 10, 1997
PROFILE MAMMOGRAPHY SYSTEM (M-PRO)
IZH
System, X-ray, Mammographic
57d
Cleared
Jan 07, 1997
GENIE PROCESSING AND REVIEW WORKSTATION
KPS
System, Tomography, Computed, Emission
92d
Cleared
Jan 03, 1997
RFA-300, LDA UTILITY
IYE
Accelerator, Linear, Medical
267d
Cleared
Jan 02, 1997
VINGMED SOUND COLOR FLOW MAPPING SYSTEM
IYO
System, Imaging, Pulsed Echo, Ultrasonic
178d
Cleared
Jan 02, 1997
ACURAY DIGITAL X-RAY
EHD
Unit, X-ray, Extraoral With Timer
126d
Cleared
Dec 23, 1996
SCATTER CORRECTION VOLUME SOFTWARE MODEL NSSC-020A
KPS
System, Tomography, Computed, Emission
290d
Cleared
Dec 23, 1996
H.A.M. APPLICATOR
JAQ
System, Applicator, Radionuclide, Remote-controlled
242d
Cleared
Dec 23, 1996
ULTRAMIX
ITX
Transducer, Ultrasonic, Diagnostic
208d
Cleared
Dec 23, 1996
FLEXART V3.1 SOFTWARE
LNH
System, Nuclear Magnetic Resonance Imaging
203d
Cleared
Dec 23, 1996
ECOLOTION TRANSMISSION AND MASSAGE LOTION
ITX
Transducer, Ultrasonic, Diagnostic
168d
Cleared
Dec 23, 1996
BELRAY/MODEL 096, DENTAL INTRAORAL X-RAY
EHD
Unit, X-ray, Extraoral With Timer
98d
Cleared
Dec 23, 1996
THE NOMOS TALON POSITIONING AND IMMOBILIZATION SYSTEM
IYE
Accelerator, Linear, Medical
88d
Cleared
Dec 23, 1996
SERIES 9600 MOBILE DIGITAL IMAGING SYSTEM
OWB
Interventional Fluoroscopic X-ray System
82d
Cleared
Dec 23, 1996
PHILIPS EASYVISION
LLZ
System, Image Processing, Radiological
81d
Cleared
Dec 23, 1996
ORTHORALIX E/GX-9000 PANORAMIC X-RAY SYSTEM
EHD
Unit, X-ray, Extraoral With Timer
33d
Cleared
Dec 18, 1996
FILM SCANNER 300
LMA
Digitizer, Image, Radiological
296d
Cleared
Dec 18, 1996
TOMTEC ECHO-SCAN
IYO
System, Imaging, Pulsed Echo, Ultrasonic
86d
Cleared
Dec 18, 1996
QLVA PLUS
LLZ
System, Image Processing, Radiological
83d
Cleared
Dec 18, 1996
LASERSHARE PRINT SPOOLER AND/OR SOFTWARE
LMD
System, Digital Image Communications, Radiological
85d
Cleared
Dec 18, 1996
C-ARM TABLE IVS-100
JAA
System, X-ray, Fluoroscopic, Image-intensified
83d
Cleared
Dec 18, 1996
MOBILE CT PROSPEED FAMILY
JAK
System, X-ray, Tomography, Computed
82d
Cleared
Dec 18, 1996
IMIG-MRI
LNH
System, Nuclear Magnetic Resonance Imaging
77d
Cleared
Dec 18, 1996
PHILIPS COMPUTED RADIOGRAPHY
LLZ
System, Image Processing, Radiological
64d
Looking for a specific radiology device? Search by device name, K-number or manufacturer.
Search all Radiology 510(k) devices