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
12835 Radiology devices
Cleared
May 12, 1999
PHILIPS EASY VISION FAMILY WORKSTATION LEGS OPTION
LLZ
System, Image Processing, Radiological
89d
Cleared
May 11, 1999
ADVANCED DIAGNOSTIC VIEWER (AOX), MODEL VITRED 1.3
LLZ
System, Image Processing, Radiological
90d
Cleared
May 11, 1999
3.0T SIGNA VH/I MAGNETIC RESONANCE SYSTEM
LNH
System, Nuclear Magnetic Resonance Imaging
78d
Cleared
May 05, 1999
SCANFLEX SOLID COUPLANT MEMBRANE
ITX
Transducer, Ultrasonic, Diagnostic
197d
Cleared
May 05, 1999
CTS-310(B)
IYO
System, Imaging, Pulsed Echo, Ultrasonic
166d
Cleared
May 05, 1999
APOLLO 5, APOLLO 10
IYE
Accelerator, Linear, Medical
86d
Cleared
Apr 30, 1999
AU6
IYN
System, Imaging, Pulsed Doppler, Ultrasonic
84d
Cleared
Apr 30, 1999
ORTHOPHOS 3/3 CEPH/3 DS
MUH
System, X-ray, Extraoral Source, Digital
70d
Cleared
Apr 21, 1999
THORAX FD AND MULTIX FD
MQB
Solid State X-ray Imager (flat Panel/digital Imager)
181d
Cleared
Apr 21, 1999
SHIMADZU WHOLE BODY X-RAY COMPUTED TOMOGRAPHY SCANNER SCT-7000TX W/FLURO OPTION
JAK
System, X-ray, Tomography, Computed
153d
Cleared
Apr 21, 1999
SHEATHES (NON-LATEX), STERILE
ITX
Transducer, Ultrasonic, Diagnostic
92d
Cleared
Apr 20, 1999
FREIBURG FLAP APPLICATOR SET, PART NUMBER 089.095
JAQ
System, Applicator, Radionuclide, Remote-controlled
209d
Cleared
Apr 16, 1999
BEACON, MODEL 211060
KPS
System, Tomography, Computed, Emission
162d
Cleared
Apr 16, 1999
`BI I-125 BRACHYTHERAPHY SEED, MODEL 125SL & 125SH
KXK
Source, Brachytherapy, Radionuclide
123d
Cleared
Apr 16, 1999
DICOM IMAGE MANAGER, MODEL 3-D VISUALIZATION OPTION
IYO
System, Imaging, Pulsed Echo, Ultrasonic
80d
Cleared
Apr 16, 1999
SHIMADZU CEILING TUBE SUPPORT CH-30GH
KPR
System, X-ray, Stationary
43d
Cleared
Apr 15, 1999
STANDARD CT/MR APPLICATOR SET,RING CT/MR APPLICATOR SET, VAGINAL CT/MR APPLICATOR SET, FLETCHER WILLIAMSON APPLICATOR SE
JAQ
System, Applicator, Radionuclide, Remote-controlled
204d
Cleared
Apr 15, 1999
OPART
LNH
System, Nuclear Magnetic Resonance Imaging
78d
Cleared
Apr 15, 1999
VIEW COM
LLZ
System, Image Processing, Radiological
38d
Cleared
Apr 15, 1999
STRAIGHT ASPIRATOR, 90 DEGREE ASPIRATOR,45 DEGREE ASPIRATOR,7 FRENCH ASPIRATOR,EXTENDED STRAIGHT ASPIRATOR,13.9 CM STRAG
LLZ
System, Image Processing, Radiological
28d
Cleared
Apr 07, 1999
SONOACE 6000C DIAGNOSTIC ULTRASOUND SYSTEM AND TRANSDUCERS, ALSO CALLED ULTRASOUND SYSTEM AND TRANSDUCERS
IYN
System, Imaging, Pulsed Doppler, Ultrasonic
15d
Cleared
Apr 05, 1999
ANGIO-CT MIYABI
IXI
Block, Beam-shaping, Radiation Therapy
47d
Cleared
Apr 02, 1999
FOCUS PILOT CONTOURING WORKSTATION
IYE
Accelerator, Linear, Medical
338d
Cleared
Apr 02, 1999
TREATMENT CONTROL STATION - MICROSELECTRON-HDR CLASSIC UPGRADE, VERSION 1.20
JAQ
System, Applicator, Radionuclide, Remote-controlled
210d
Cleared
Apr 02, 1999
ROTTERDAM NASOPHAYRNX MOULD SET, PART #089.068
JAQ
System, Applicator, Radionuclide, Remote-controlled
191d
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