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
12659 Radiology devices
Cleared
May 09, 2008
4D INTEGRATED TREATMENT CONSOLE WITH PATIENT ACCESSORY VERIFICATION SYSTEM (PAVS)
IYE
Accelerator, Linear, Medical
28d
Cleared
May 09, 2008
GE LIGHTSPEED CT750 HD (LIGHTSPEED 8.0)
JAK
System, X-ray, Tomography, Computed
21d
Cleared
May 09, 2008
MAMMOSITE CAVITY EVALUATION DEVICE
JAQ
System, Applicator, Radionuclide, Remote-controlled
14d
Cleared
May 05, 2008
BRACHYTHERAPY SOURCE DEVICE, MODEL 9011
IWG
Seed, Isotope, Gold, Titanium, Platinum
20d
Cleared
May 02, 2008
OEC 9900 ELITE
OWB
Interventional Fluoroscopic X-ray System
137d
Cleared
May 02, 2008
CONTURA MLB SOURCE APPLICATOR FOR BRACHYTHERAPY
JAQ
System, Applicator, Radionuclide, Remote-controlled
16d
Cleared
May 02, 2008
CORONIS 5MP MAMMO SL, MODEL MDMG 6121
LLZ
System, Image Processing, Radiological
14d
Cleared
May 02, 2008
NORAS MR-BI320-PA 1.5T
MOS
Coil, Magnetic Resonance, Specialty
11d
Cleared
May 01, 2008
3-D IMAGING WORKSTATION
LLZ
System, Image Processing, Radiological
14d
Cleared
Apr 30, 2008
CONTURA MULTI-LUMEN BALLOON SOURCE APPLICATOR FOR BRACHYTHERAPY, MODELS B001-45 AND B011-45
JAQ
System, Applicator, Radionuclide, Remote-controlled
41d
Cleared
Apr 29, 2008
TROCAR POINT TITANIUM NEEDLE SETS, ROUND POINT TITANIUM NEEDLE SETS
JAQ
System, Applicator, Radionuclide, Remote-controlled
29d
Cleared
Apr 29, 2008
KODAK 9000C EXTRAORAL IMAGING SYSTEM
MUH
System, X-ray, Extraoral Source, Digital
29d
Cleared
Apr 29, 2008
SMARTSPOT PRIMAX
LLZ
System, Image Processing, Radiological
29d
Cleared
Apr 29, 2008
S-SCAN, G-SCAN, DYNAMIC MRI SOFTWARE FOR C-SCAN, E-SCANXQ & E-SCAN OPERA
LNH
System, Nuclear Magnetic Resonance Imaging
25d
Cleared
Apr 29, 2008
GEMINI CONDOR
KPS
System, Tomography, Computed, Emission
8d
Cleared
Apr 25, 2008
LUMIMED SERIES 5MP DIGITAL FLAT PANEL DISPLAY SYSTEM, MODEL MM50/MM50A
LLZ
System, Image Processing, Radiological
148d
Cleared
Apr 25, 2008
ACUSON X300 ULTRASOUND SYSTEM
IYN
System, Imaging, Pulsed Doppler, Ultrasonic
38d
Cleared
Apr 25, 2008
SYNGO DYNAMICS VERSION 7.0
LLZ
System, Image Processing, Radiological
15d
Cleared
Apr 25, 2008
SIGNA 3.0T MR750 SYSTEM
LNH
System, Nuclear Magnetic Resonance Imaging
14d
Cleared
Apr 22, 2008
SYNGO MULTIMODALITY WORKPLACE
LLZ
System, Image Processing, Radiological
209d
Cleared
Apr 22, 2008
DEXELA DEX TOP MAMMOGRAPHY WORKSTATION, MODEL MAMWKVI
LLZ
System, Image Processing, Radiological
71d
Cleared
Apr 18, 2008
FCR GO PORTABLE DIGITAL X-RAY SYSTEM
IZL
System, X-ray, Mobile
15d
Cleared
Apr 18, 2008
NM APPLICATION SUITE
LLZ
System, Image Processing, Radiological
14d
Cleared
Apr 17, 2008
DIGITAL LIGHTBOX
LLZ
System, Image Processing, Radiological
44d
Cleared
Apr 16, 2008
SURGICASE
LLZ
System, Image Processing, Radiological
128d
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