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
12656 Radiology devices
Cleared
May 29, 2008
19-INCH (48CM) 1.3M COLOR LCD MONITOR CDL1909A
LLZ
System, Image Processing, Radiological
56d
Cleared
May 29, 2008
15-INCH (38 CM) COLOR LCD MONITOR CDL1576A
LLZ
System, Image Processing, Radiological
56d
Cleared
May 28, 2008
VIENNA RING CT/MR APPLICATOR SET, ROUND POINT TITANIUM NEEDLE SET, TROCAR POINT TITANIUM NEEDLE SET
JAQ
System, Applicator, Radionuclide, Remote-controlled
56d
Cleared
May 28, 2008
WBR XPRESS3.CARDIAC
KPS
System, Tomography, Computed, Emission
30d
Cleared
May 28, 2008
ILUMA VISION
LLZ
System, Image Processing, Radiological
14d
Cleared
May 27, 2008
DC-3, DC-3T DIAGNOSTIC ULTRASOUND SYSTEM
IYN
System, Imaging, Pulsed Doppler, Ultrasonic
15d
Cleared
May 23, 2008
MROPEN
LNH
System, Nuclear Magnetic Resonance Imaging
175d
Cleared
May 23, 2008
ULTRASOUND SCANNER FLEX FOCUS, MODEL 1202
IYO
System, Imaging, Pulsed Echo, Ultrasonic
30d
Cleared
May 20, 2008
OCENTRA MASTERPLAN 3.1 (OCENTRA BRACHY)
MUJ
System, Planning, Radiation Therapy Treatment
14d
Cleared
May 16, 2008
BI-RADS COMPANION
LLZ
System, Image Processing, Radiological
276d
Cleared
May 16, 2008
FMRI HARDWARE SYSTEM
LNH
System, Nuclear Magnetic Resonance Imaging
81d
Cleared
May 16, 2008
SIUI CTS-900 DIGITAL ULTRASOUND IMAGING SYSTEM
IYO
System, Imaging, Pulsed Echo, Ultrasonic
28d
Cleared
May 15, 2008
MEDICATECH, MODEL DDR MAK-800, DDT MAK-1000 FS, DDR MAK-1100 FA
KPR
System, X-ray, Stationary
73d
Cleared
May 15, 2008
IB NEURO, VERSION 1.0
LNH
System, Nuclear Magnetic Resonance Imaging
58d
Cleared
May 14, 2008
SHIMADZU MOBILE X-RAY SYSTEM MOBILEDART EVOLUTION
IZL
System, X-ray, Mobile
64d
Cleared
May 14, 2008
CALYPSO 4D LOCALIZATION SYSTEM
IYE
Accelerator, Linear, Medical
61d
Cleared
May 13, 2008
CORRIDOR4DM
KPS
System, Tomography, Computed, Emission
74d
Cleared
May 13, 2008
DENTRON SENSOR
EAP
Unit, X-ray, Intraoral
57d
Cleared
May 09, 2008
AXXENT VAGINAL APPLICATOR
JAD
System, Therapeutic, X-ray
235d
Cleared
May 09, 2008
LEICA FL800
IZI
System, X-ray, Angiographic
66d
Cleared
May 09, 2008
CHRYSALIS
KPR
System, X-ray, Stationary
63d
Cleared
May 09, 2008
VERISUITE 1.6, VERISUITE-PARTICLE 1.6
IYE
Accelerator, Linear, Medical
53d
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
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