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
12648 Radiology devices
Cleared
Jan 09, 2009
IMAGESVR PACS
LLZ
System, Image Processing, Radiological
107d
Cleared
Jan 08, 2009
KUBTEC XPERT 20
KPR
System, X-ray, Stationary
43d
Cleared
Jan 08, 2009
WORLDWIDE MEDICAL TECHNOLOGIES ANCHOR MARKER, MARKER STRAND AND MARKER
KXK
Source, Brachytherapy, Radionuclide
63d
Cleared
Jan 05, 2009
CARDIO VUE QUANTITATIVE ANALYSIS (CVQ)
LLZ
System, Image Processing, Radiological
125d
Cleared
Dec 30, 2008
CARESTREAM PACS, MODEL CARESTREAM PACS VII
LLZ
System, Image Processing, Radiological
19d
Cleared
Dec 29, 2008
IKOENGELO, VERSION 2
KPQ
System, Simulation, Radiation Therapy
25d
Cleared
Dec 23, 2008
TT1 GENERAL PURPOSE COIL
MOS
Coil, Magnetic Resonance, Specialty
33d
Cleared
Dec 23, 2008
IMAGE-ARENA APPLICATIONS
LLZ
System, Image Processing, Radiological
40d
Cleared
Dec 23, 2008
HELIODENT PLUS
EHD
Unit, X-ray, Extraoral With Timer
40d
Cleared
Dec 23, 2008
RSVP HALF SPHERE PHANTOM, MODEL DDP010
IYE
Accelerator, Linear, Medical
84d
Cleared
Dec 22, 2008
SIEMENS ACUSON 2000 ULTRASOUND SYSTEM WITH ABVS TRANSDUCER
IYO
System, Imaging, Pulsed Echo, Ultrasonic
244d
Cleared
Dec 19, 2008
ALOKA PROUSOUND 2 DIAGNOSTIC ULTRASOUND SYSTEM
IYN
System, Imaging, Pulsed Doppler, Ultrasonic
45d
Cleared
Dec 19, 2008
CT BRAIN PERFUSION FOR ZIOSTATION
LLZ
System, Image Processing, Radiological
64d
Cleared
Dec 17, 2008
PHILIPS MODEL MX 16 SLICE CT SYSTEM
JAK
System, X-ray, Tomography, Computed
22d
Cleared
Dec 17, 2008
STASYS MOTION CORRECTION SOFTWARE
KPS
System, Tomography, Computed, Emission
78d
Cleared
Dec 16, 2008
PICTURE ARCHIVING AND COMMUNICATION SYSTEM (PACS), PETAVISION
LLZ
System, Image Processing, Radiological
14d
Cleared
Dec 16, 2008
NEURO III-SV
LNH
System, Nuclear Magnetic Resonance Imaging
54d
Cleared
Dec 15, 2008
DIAGNOSTIC ULTRASOUND SYSTEM SARANO, ECHO VIEW, SHIMASONIC
ITX
Transducer, Ultrasonic, Diagnostic
131d
Cleared
Dec 12, 2008
DC-3/DC-3T DIAGNOSTIC ULTRASOUND SYSTEM
IYN
System, Imaging, Pulsed Doppler, Ultrasonic
16d
Cleared
Dec 12, 2008
GE DISCOVERY NM/CT 570C
KPS
System, Tomography, Computed, Emission
16d
Cleared
Dec 12, 2008
MODEL TSX-301B AQUILION CT SYSTEM
JAK
System, X-ray, Tomography, Computed
35d
Cleared
Dec 12, 2008
IBA PROTON THERAPY SYSTEM- PROTEUS 235
LHN
System, Radiation Therapy, Charged-particle, Medical
113d
Cleared
Dec 12, 2008
VISAGE PACS, VERSION 6.0/CS 3.1
LLZ
System, Image Processing, Radiological
123d
Cleared
Dec 05, 2008
VIATRONIX V3D-CARDIAC, REVISION 1.0
JAK
System, X-ray, Tomography, Computed
25d
Cleared
Dec 05, 2008
ECHELON HIGH RESOLUTION FOOT COIL (MR-HRF-150), ECHELON LONG BONE COIL (MR-LBC-150)
MOS
Coil, Magnetic Resonance, Specialty
50d
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