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
12750 Radiology devices
Cleared
Jan 06, 2005
HD11 DIAGNOSTIC ULTRASOUND SYSTEM
IYN
System, Imaging, Pulsed Doppler, Ultrasonic
15d
Cleared
Jan 05, 2005
IMT.LAB
LLZ
System, Image Processing, Radiological
29d
Cleared
Jan 04, 2005
HORIZON MEDICAL IMAGING
LLZ
System, Image Processing, Radiological
50d
Cleared
Dec 30, 2004
MASEP SRRS GAMMA RAYS STEREOTACTIC RADIATION THERAPY SYSTEM FOR HEADS (MASEP GAMMA THERAPY SYSTEM)
IWB
System, Radiation Therapy, Radionuclide
244d
Cleared
Dec 30, 2004
CORONIS 5MP MEDICAL FLAT PANEL DISPLAY SYSTEM
LLZ
System, Image Processing, Radiological
135d
Cleared
Dec 23, 2004
SURGPLAN AND PANPLAN
LLZ
System, Image Processing, Radiological
241d
Cleared
Dec 23, 2004
SONATA 3-D IMAGING ACCESSORY, MODEL 3DS
IYO
System, Imaging, Pulsed Echo, Ultrasonic
87d
Cleared
Dec 23, 2004
SOMATOM RESPIRATORY GATING
JAK
System, X-ray, Tomography, Computed
45d
Cleared
Dec 23, 2004
INFINIA LIGHTSPEED
KPS
System, Tomography, Computed, Emission
14d
Cleared
Dec 22, 2004
GE OEC FLUOROSTAR
OWB
Interventional Fluoroscopic X-ray System
44d
Cleared
Dec 21, 2004
TITAN HIGH RESOLUTION ULTRASOUND SYSTEM AND SONOSITE ULTRASOUND SYSTEM
IYN
System, Imaging, Pulsed Doppler, Ultrasonic
6d
Cleared
Dec 21, 2004
SA8000 SE DIAGNOSTIC ULTRASOUND SYSTEM
IYN
System, Imaging, Pulsed Doppler, Ultrasonic
6d
Cleared
Dec 20, 2004
MODIFICATION TO: VIEWSTATION
LLZ
System, Image Processing, Radiological
10d
Cleared
Dec 17, 2004
MINI-GAMMA CAMERA, MODELS MGC500-101U AND MGC500-301U
KPS
System, Tomography, Computed, Emission
18d
Cleared
Dec 17, 2004
CRANEX D
EHD
Unit, X-ray, Extraoral With Timer
16d
Cleared
Dec 15, 2004
DIRECT DIGITIZER, REGIUS MODEL 190
MQB
Solid State X-ray Imager (flat Panel/digital Imager)
104d
Cleared
Dec 15, 2004
SCENIUM
KPS
System, Tomography, Computed, Emission
58d
Cleared
Dec 15, 2004
SOMATOM CARE CONTRAST CT
JAK
System, X-ray, Tomography, Computed
37d
Cleared
Dec 15, 2004
VITREA2, VERSION 3.7 MEDICAL IMAGE PROCESSING SYSTEM
LLZ
System, Image Processing, Radiological
12d
Cleared
Dec 15, 2004
MISTAR, MODEL V3.2
LLZ
System, Image Processing, Radiological
9d
Cleared
Dec 13, 2004
MODEL SR-130-D PORTABLE DIGITAL X-RAY SYSTEM
IZL
System, X-ray, Mobile
38d
Cleared
Dec 13, 2004
PREVA, 76IN ARM, 66IN ARM, 56IN ARM, MODELS P7017, P7016, P7015
EHD
Unit, X-ray, Extraoral With Timer
34d
Cleared
Dec 13, 2004
METRX WORKSTATION
LLZ
System, Image Processing, Radiological
31d
Cleared
Dec 13, 2004
TERATECH MODEL 8IOC4, 8IOL4 & 10LAP4 PROBES
ITX
Transducer, Ultrasonic, Diagnostic
17d
Cleared
Dec 10, 2004
PALMSCAN AP2000
IYO
System, Imaging, Pulsed Echo, Ultrasonic
11d
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