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FDA 510(k), K103720, SYNAPSE 3D LUNG AND ABDOMEN ANALYSIS
FDA 510(k), K103720, SYNAPSE 3D LUNG AND ABDOMEN ANALYSIS
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510(K) Number: K103720
Device Name: SYNAPSE 3D LUNG AND ABDOMEN ANALYSIS
Manufacturer: FUJIFILM MEDICAL SYSTEMS U.S.A., INC.
Device Classification Name: System, Image Processing, Radiological
Regulation Number: 892.2050
Classification Product Code: LLZ
Date Received: 12/21/2010
Decision Date: 03/16/2011
Regulation Medical Specialty: Radiology
Device Name: SYNAPSE 3D LUNG AND ABDOMEN ANALYSIS
Manufacturer: FUJIFILM MEDICAL SYSTEMS U.S.A., INC.
Device Classification Name: System, Image Processing, Radiological
Regulation Number: 892.2050
Classification Product Code: LLZ
Date Received: 12/21/2010
Decision Date: 03/16/2011
Regulation Medical Specialty: Radiology
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
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