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Fujifilm Medical Systems U.S.A, Inc.

5 FDA 510(k) clearances · PMA applicant

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RecordFirmDate
ASPIRE Cristalle Digital Breast Tomosynthesis (DBT) Option (P160031/S004)Fujifilm Medical Systems U.S.A, Inc.2023-02-13
ASPIRE Cristalle Digital Breast Tomosynthesis (DBT) Option (P160031/S003)Fujifilm Medical Systems U.S.A, Inc.2020-09-30
Aspire Cristalle Digital Breast Tomosynthesis Option (P160031/S002)Fujifilm Medical Systems U.S.A, Inc.2019-10-25
ASPIRE Cristalle Breast Tomosynthesis System (P160031/S001)Fujifilm Medical Systems U.S.A, Inc.2019-02-08
ASPIRE CRISTALLE DIGITAL BREAST TOMOSYNTHESIS OPTION (P160031)Fujifilm Medical Systems U.S.A, Inc.2017-01-10

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Every clearance here is in the API, with alerts when new ones post.