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FDA 510(k), K130542, SYNAPSE 3D LUNG AND ABDOMEN ANALYSIS
FDA 510(k), K130542, SYNAPSE 3D LUNG AND ABDOMEN ANALYSIS
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510(K) Number: K130542
Device Name: SYNAPSE 3D LUNG AND ABDOMEN ANALYSIS
Manufacturer: FUJIFILM MEDICAL SYSTEM U.S.A., INC.
Device Classification Name: system, image processing, radiological
Regulation Number: 892.2050
Classification Product Code: LLZ
Date Received: 03/01/2013
Decision Date: 06/14/2013
Regulation Medical Specialty: Radiology
Device Name: SYNAPSE 3D LUNG AND ABDOMEN ANALYSIS
Manufacturer: FUJIFILM MEDICAL SYSTEM U.S.A., INC.
Device Classification Name: system, image processing, radiological
Regulation Number: 892.2050
Classification Product Code: LLZ
Date Received: 03/01/2013
Decision Date: 06/14/2013
Regulation Medical Specialty: Radiology
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
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