Mammo Tomosynthesis (MDMG-5221)— 510(k) K161229

Substantially Equivalent

Barco N.V.

FDA 510(k) clearance K161229 for Mammo Tomosynthesis (MDMG-5221), Substantially Equivalent on 2016-05-18. Applicant: Barco N.V..

Clearance details

Applicant: Barco N.V.
Product code: Code PGY
Advisory panel: Radiology
Date received: 2016-05-02
Decision date: 2016-05-18
Decision: Substantially Equivalent
Clearance type: Special
Location: Kortrijk, BE

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