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
12720 Radiology devices
Cleared
Jul 28, 2006
CARDIOVASCULAR ARRAY COILS, MODELS CAC-63-16, CAC-63-32, CAC-123-32 AND CAC-127-16
MOS
Coil, Magnetic Resonance, Specialty
18d
Cleared
Jul 27, 2006
TOPSLANE DMLC
IXI
Block, Beam-shaping, Radiation Therapy
184d
Cleared
Jul 27, 2006
ECHO VIEW/SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-1200PRO
IYN
System, Imaging, Pulsed Doppler, Ultrasonic
45d
Cleared
Jul 27, 2006
SYNGO MULTIMODALITY WORKPLACE
LLZ
System, Image Processing, Radiological
15d
Cleared
Jul 25, 2006
ERAD PACS
LLZ
System, Image Processing, Radiological
64d
Cleared
Jul 25, 2006
DYNAMIC MRI SOFTWARE OPTION FOR C-SCAN, E-SCAN XQ AND E-SCAN OPERA
LNH
System, Nuclear Magnetic Resonance Imaging
63d
Cleared
Jul 25, 2006
SYNGO EXPERT-1
JAK
System, X-ray, Tomography, Computed
61d
Cleared
Jul 25, 2006
VARISOURCE 200 HDR AFTERLOADER
JAQ
System, Applicator, Radionuclide, Remote-controlled
48d
Cleared
Jul 25, 2006
ECHOVIEW/ SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-2200PRO
IYN
System, Imaging, Pulsed Doppler, Ultrasonic
43d
Cleared
Jul 25, 2006
INTEGRA RADIONICS XKNIFE RT 4
MUJ
System, Planning, Radiation Therapy Treatment
22d
Cleared
Jul 25, 2006
21.3 INCH MONOCHROME LCD MONITOR
LLZ
System, Image Processing, Radiological
15d
Cleared
Jul 21, 2006
NOMOSSTAT, VERSION 1.0
IYE
Accelerator, Linear, Medical
109d
Cleared
Jul 21, 2006
QUANTIVA
LLZ
System, Image Processing, Radiological
60d
Cleared
Jul 21, 2006
5M MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR MDL2116A (ME551I2)
LLZ
System, Image Processing, Radiological
57d
Cleared
Jul 21, 2006
MAGIS1
IYE
Accelerator, Linear, Medical
32d
Cleared
Jul 21, 2006
ACUSON X300 DIAGNOSTIC ULTRASOUND SYSTEM
IYN
System, Imaging, Pulsed Doppler, Ultrasonic
11d
Cleared
Jul 14, 2006
ECHO VIEW/SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SARANO
IYO
System, Imaging, Pulsed Echo, Ultrasonic
32d
Cleared
Jul 12, 2006
IPLAN RT DOSE
MUJ
System, Planning, Radiation Therapy Treatment
201d
Cleared
Jul 12, 2006
GE VOLUSON E8 ULTRASOUND SYSTEM
IYO
System, Imaging, Pulsed Echo, Ultrasonic
27d
Cleared
Jul 12, 2006
LIGHTSPEED 7.1 CT SCANNER SYSTEM
JAK
System, X-ray, Tomography, Computed
14d
Cleared
Jul 07, 2006
ZIEHM VARIO 3D DIGITAL MOBILE IMAGING SYSTEM
JAK
System, X-ray, Tomography, Computed
58d
Cleared
Jul 07, 2006
ZIEHM VISION FD DIGITAL MOBILE IMAGING SYSTEM
OWB
Interventional Fluoroscopic X-ray System
35d
Cleared
Jul 05, 2006
LEKSELL GAMMAPLAN
IWB
System, Radiation Therapy, Radionuclide
30d
Cleared
Jul 03, 2006
I-CAT SCANNER
MUH
System, X-ray, Extraoral Source, Digital
56d
Cleared
Jul 03, 2006
GE VIVID - I
IYN
System, Imaging, Pulsed Doppler, Ultrasonic
31d
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