FDA PMA Number P160031, ASPIRE Cristalle Breast Tomosynthesis System

FDA PMA Number P160031, ASPIRE Cristalle Breast Tomosynthesis System

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PMA Number: P160031
Device: ASPIRE Cristalle Breast Tomosynthesis System
Generic Name: Digital breast tomosynthesis
Manufacturer: FUJIFILM MEDICAL SYSTEMS U.S.A., INC.
Product Code: OTE
Date Received: 10/23/2018
Decision Date: 02/08/2019
Notice Date: 01/00/1900

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