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
12600 Radiology devices
Cleared
Dec 27, 2011
PROCEDURE REHEARSAL STUDIO(TM)
LLZ
System, Image Processing, Radiological
131d
Cleared
Dec 23, 2011
21.3 INCH (54 CM) MONOCHROME LCD MONITOR MS23I2 (ML21023)
LLZ
System, Image Processing, Radiological
32d
Cleared
Dec 23, 2011
1.5T AND 3T 8-CHANNEL MEDIUM GENERAL PURPOSE FLEX COIL
MOS
Coil, Magnetic Resonance, Specialty
191d
Cleared
Dec 23, 2011
KONICA MINOLTA XPRESS DIGITAL MAMMOGRAPHY SYSTEM
MUE
Full Field Digital, System, X-ray, Mammographic
283d
Cleared
Dec 22, 2011
SYNAPSE MPR FUSION
LLZ
System, Image Processing, Radiological
50d
Cleared
Dec 22, 2011
TOMOTHERAPY TREATMENT SYSTEM FAST OPTIMIZER
MUJ
System, Planning, Radiation Therapy Treatment
87d
Cleared
Dec 22, 2011
THE KINEGRAPH VMA SOFTWARE, THE MOTION NORMALIZER PATIENT HANDLING AND DATA COLLECTION DEVICE
LLZ
System, Image Processing, Radiological
153d
Cleared
Dec 22, 2011
CR MAMMOGRAPHY SYSTEM WITH DX-M DIGITIZER
MUE
Full Field Digital, System, X-ray, Mammographic
225d
Cleared
Dec 22, 2011
SENOGRAPHE DS, SENOGRAPHE ESSENTIAL
MUE
Full Field Digital, System, X-ray, Mammographic
275d
Cleared
Dec 20, 2011
21.3INCH (54CM)COLOR LCD MONITOR CCL256I2(CL21256)
LLZ
System, Image Processing, Radiological
57d
Cleared
Dec 20, 2011
METRON-CP/MD
LLZ
System, Image Processing, Radiological
382d
Cleared
Dec 17, 2011
BIOGRAPH MCT FAMILY
KPS
System, Tomography, Computed, Emission
26d
Cleared
Dec 17, 2011
8MP COLOR LCD MONITOR,RADIFORCE RX840
LLZ
System, Image Processing, Radiological
46d
Cleared
Dec 17, 2011
HD-IVUS ULTRASOUND IMAGING SYSTEM
IYN
System, Imaging, Pulsed Doppler, Ultrasonic
71d
Cleared
Dec 16, 2011
DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S DIAGNOSTIC ULTRASOUND SYSTEM
IYN
System, Imaging, Pulsed Doppler, Ultrasonic
4d
Cleared
Dec 16, 2011
ONDEMAND3D
LLZ
System, Image Processing, Radiological
15d
Cleared
Dec 16, 2011
CLEARSTART SVM SYSTEM
LLZ
System, Image Processing, Radiological
15d
Cleared
Dec 16, 2011
INTEGRITY(TM)
IYE
Accelerator, Linear, Medical
100d
Cleared
Dec 13, 2011
GE INNOVA SOLID STATE XRAY IMAGER FLUROSOPIC X RAY SYSTEM
IZI
System, X-ray, Angiographic
63d
Cleared
Dec 13, 2011
VIEW 1 IMAGING
LLZ
System, Image Processing, Radiological
106d
Cleared
Dec 12, 2011
ONCENTRA MANUAL LOW DOSE RATE TREATMENT PLANNING
MUJ
System, Planning, Radiation Therapy Treatment
54d
Cleared
Dec 08, 2011
ASPIRE CR FOR MAMMOGRAPHY SYSTEM (CRM)
MUE
Full Field Digital, System, X-ray, Mammographic
178d
Cleared
Dec 07, 2011
ACUSON SC2000 DIAGNOSTIC ULTRASOUND SYSTEM
IYN
System, Imaging, Pulsed Doppler, Ultrasonic
40d
Cleared
Dec 06, 2011
DENTAL 3D PLANNING SOFTWARE
LLZ
System, Image Processing, Radiological
18d
Cleared
Dec 05, 2011
BRIVO NM 615
KPS
System, Tomography, Computed, Emission
21d
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