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
12847 Radiology devices
Cleared
Apr 17, 1998
SWARTZ DOPPLER FLOW PROBE AND MONITOR SYSTEM
ITX
Transducer, Ultrasonic, Diagnostic
557d
Cleared
Apr 17, 1998
VIDAR VXR LS LASER FILM DIGITIZER
LMA
Digitizer, Image, Radiological
151d
Cleared
Apr 17, 1998
OLDELFT DIGIDELCA
KPR
System, X-ray, Stationary
80d
Cleared
Apr 17, 1998
PLANMECA DIXI, DIGITAL INTRAORAL X-RAY IMAGING SYSTEM
EHD
Unit, X-ray, Extraoral With Timer
59d
Cleared
Apr 15, 1998
IMEX MEDICAL SYSTEMS, INC. IMEXLAB 9100
IYN
System, Imaging, Pulsed Doppler, Ultrasonic
208d
Cleared
Apr 14, 1998
DENOPTIX BARRIER ENVELOPE (SIZE 0-4)
EHD
Unit, X-ray, Extraoral With Timer
61d
Cleared
Apr 13, 1998
PREMIER 7000 CTL SPINE COIL
MOS
Coil, Magnetic Resonance, Specialty
87d
Cleared
Apr 13, 1998
HISPEED LX//I, HISPEED FX/I, AND HISPEED DX/I FAMILY OF SYSTEMS
JAK
System, X-ray, Tomography, Computed
87d
Cleared
Apr 13, 1998
HISPEED QX/I CT SCANNER SYSTEM
JAK
System, X-ray, Tomography, Computed
83d
Cleared
Apr 09, 1998
LUBRISCAN ULTRA SCAN GEL +, MODEL RG2-60
ITX
Transducer, Ultrasonic, Diagnostic
90d
Cleared
Apr 09, 1998
REMOTE HAND CONTROL TO THE INFLATABLE POSITIONING CUSHION (A.K.A. IMAGEAIR)
IZH
System, X-ray, Mammographic
77d
Cleared
Apr 09, 1998
BARCO MGD 521 5 MEGAPIXEL DIAGNOSTIC DISPLAY
LMD
System, Digital Image Communications, Radiological
57d
Cleared
Apr 03, 1998
PARAMETER DEVELOPMENTS DICOM ARCHIVAL SERVER, (DAS)/DICOM INTRANET SERVICE (DIS)
LMB
Device, Digital Image Storage, Radiological
70d
Cleared
Apr 02, 1998
COMPUTED RADIOGRAPHY QUALITY ASSURANCE SOFTWARE
LLZ
System, Image Processing, Radiological
76d
Cleared
Apr 02, 1998
GYREX 2T PRESTIGE, GYREX PRIMA ITG, GYREX PRIVILEGE, GYREX V-EP
LNH
System, Nuclear Magnetic Resonance Imaging
65d
Cleared
Apr 02, 1998
HDI 1000 DIAGNOSTIC ULTRASOUND SYSTEM
IYO
System, Imaging, Pulsed Echo, Ultrasonic
28d
Cleared
Apr 01, 1998
LEKSELL GAMMAPLAN
IWB
System, Radiation Therapy, Radionuclide
202d
Cleared
Mar 30, 1998
SHIELDED CABINET X-RAY RADIATION SOURCE DEVICE MODEL RS 3000
MOT
Irradiator, Blood To Prevent Graft Versus Host Disease
140d
Cleared
Mar 30, 1998
MAGNETIC RESONANCE DIAGNOSTIC SYSTEM
LNH
System, Nuclear Magnetic Resonance Imaging
76d
Cleared
Mar 27, 1998
CRANEX TOME CEPH, OR CRANEX TOME
EHD
Unit, X-ray, Extraoral With Timer
88d
Cleared
Mar 23, 1998
THE TCS-MEDCON'S TELECARDIOLOGY SYSTEM
IZI
System, X-ray, Angiographic
98d
Cleared
Mar 23, 1998
TRIMAX RADIOGRAPHIC CASSETTE
IXA
Cassette, Radiographic Film
27d
Cleared
Mar 19, 1998
LD2000 SERIES
LMA
Digitizer, Image, Radiological
34d
Cleared
Mar 18, 1998
ASU-1000 DIAGNOSTIC ULTRASOUND TRANSDUCER
ITX
Transducer, Ultrasonic, Diagnostic
104d
Cleared
Mar 17, 1998
IMIX DIGITAL THORAX SYSTEM
KPR
System, X-ray, Stationary
78d
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