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
12727 Radiology devices
Cleared
Apr 25, 2006
MONOCHROME LCD MONITOR, RADIFORCE MODEL GS310
LLZ
System, Image Processing, Radiological
28d
Cleared
Apr 24, 2006
IVA (MXA II SOFTWARE OPTION)
KGI
Densitometer, Bone
97d
Cleared
Apr 24, 2006
DIGIREX DIGITAL DENTAL RADIOGRAPHY SYSTEM
EHD
Unit, X-ray, Extraoral With Timer
45d
Cleared
Apr 21, 2006
SURTRAK IMPLANTATION KIT
KXK
Source, Brachytherapy, Radionuclide
37d
Cleared
Apr 19, 2006
SOURCE PRODUCTION & EQUIPMENT CO, INC., MODEL M-19 IR-192 BRACHYTHERAPY SOURCE
JAQ
System, Applicator, Radionuclide, Remote-controlled
181d
Cleared
Apr 19, 2006
IVIEW
IYO
System, Imaging, Pulsed Echo, Ultrasonic
142d
Cleared
Apr 19, 2006
ABARIS
JAK
System, X-ray, Tomography, Computed
113d
Cleared
Apr 19, 2006
GE LIGHTSPEED XTRA CT SCANNER SYSTEM
JAK
System, X-ray, Tomography, Computed
103d
Cleared
Apr 19, 2006
PALLADIUM-103 SEED IMPLANT KITS -MULTIPLE
KXK
Source, Brachytherapy, Radionuclide
40d
Cleared
Apr 19, 2006
PROBEAT WITH MGCS
LHN
System, Radiation Therapy, Charged-particle, Medical
23d
Cleared
Apr 19, 2006
MODEL EC9-4 TRANSDUCER
ITX
Transducer, Ultrasonic, Diagnostic
19d
Cleared
Apr 19, 2006
MODIFICATION TO: HI-ART SYSTEM
IYE
Accelerator, Linear, Medical
16d
Cleared
Apr 19, 2006
CAAS MRV VERSION 3.0
LLZ
System, Image Processing, Radiological
13d
Cleared
Apr 19, 2006
SONICATH ULTRA IMAGING CATHETER, 3.2F,20MHZ MODELS 37410/456221/C1020
ITX
Transducer, Ultrasonic, Diagnostic
13d
Cleared
Apr 14, 2006
VANGUARD MRI AUXILIARY PATIENT TABLE WITH 4 AND 8 CHANNEL COIL ARRAY FOR GE SIGNA SYSTEMS
MOS
Coil, Magnetic Resonance, Specialty
15d
Cleared
Apr 14, 2006
GALILEOS
MUH
System, X-ray, Extraoral Source, Digital
11d
Cleared
Apr 11, 2006
HDR 1000 PLUS WELL CHAMBER, MODEL 90008
JAQ
System, Applicator, Radionuclide, Remote-controlled
42d
Cleared
Apr 11, 2006
VUMAX
IYO
System, Imaging, Pulsed Echo, Ultrasonic
33d
Cleared
Apr 11, 2006
IBA PROTON THERAPY SYSTEM - PROTEUS 235
LHN
System, Radiation Therapy, Charged-particle, Medical
26d
Cleared
Apr 10, 2006
STETHOFLUX
JAF
Monitor, Ultrasonic, Nonfetal
91d
Cleared
Apr 10, 2006
ECHOHEART TRANSVAGINAL DOPPLER PROBE
HEK
Monitor, Heart Sound, Fetal, Ultrasonic
53d
Cleared
Apr 07, 2006
SEEKER/SPARK ULTRASOUND SYSTEM
IYO
System, Imaging, Pulsed Echo, Ultrasonic
14d
Cleared
Apr 07, 2006
SVIEW
LLZ
System, Image Processing, Radiological
10d
Cleared
Apr 06, 2006
ROTATING GAMMA SYSTEM. GAMMA ART-6000
IWB
System, Radiation Therapy, Radionuclide
57d
Cleared
Apr 05, 2006
MINXRAY, MODELS HFP24 AND HFP40
IZL
System, X-ray, Mobile
33d
Looking for a specific radiology device? Search by device name, K-number or manufacturer.
Search all Radiology 510(k) devices