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FDA 510(k), K161229, Mammo Tomosynthesis (MDMG-5221)
FDA 510(k), K161229, Mammo Tomosynthesis (MDMG-5221)
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510(K) Number: K161229
Device Name: Mammo Tomosynthesis (MDMG-5221)
Manufacturer: BARCO N.V.
Device Classification Name: Display, Diagnostic Radiology
Regulation Number: 892.2050
Classification Product Code: PGY
Date Received: 05/02/2016
Decision Date: 05/18/2016
Regulation Medical Specialty: Radiology
Device Name: Mammo Tomosynthesis (MDMG-5221)
Manufacturer: BARCO N.V.
Device Classification Name: Display, Diagnostic Radiology
Regulation Number: 892.2050
Classification Product Code: PGY
Date Received: 05/02/2016
Decision Date: 05/18/2016
Regulation Medical Specialty: Radiology
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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