FDA 510(k)

Mammo Tomosynthesis (MDMG-5221)

K-Number: K161229 · 2016-05-18

Decision Date2016-05-18

Product CodePGY

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

Mammo Tomosynthesis (MDMG-5221) is a medical device manufactured by Barco N.V.. It received FDA 510(k) clearance on 2016-05-18 under approval number K161229. The device is classified under product code PGY. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Mammo Tomosynthesis (MDMG-5221)?

Mammo Tomosynthesis (MDMG-5221) is a medical device that received FDA 510(k) clearance on 2016-05-18. It is manufactured by Barco N.V.. The 510(k) number is K161229.

When was Mammo Tomosynthesis (MDMG-5221) approved by the FDA?

Mammo Tomosynthesis (MDMG-5221) received FDA 510(k) clearance on 2016-05-18, under approval number K161229.

What company makes Mammo Tomosynthesis (MDMG-5221)?

Mammo Tomosynthesis (MDMG-5221) is manufactured by Barco N.V..

What is the FDA product code for Mammo Tomosynthesis (MDMG-5221)?

The FDA product code for Mammo Tomosynthesis (MDMG-5221) is PGY.

Other Devices by Barco N.V.

K172922MMPC-4127F1 K171812Nio Color 2MP (MDNC-2123) K170537Nexxis OR, Nexxis K170837Nio Color 3MP (MDNC-3421) K170476Nio Color 5.8MP (MDNC-6121) K161880NIVR58-T kit

View all 18 devices →

Related Devices (Code: PGY)

K1633356MP Color LCD Monitor, RadiForce RX660, RX660-AREizo Corporation K1625278MP Color LCD Monitor (C81W+)Shenzhen Beacon Display Technology Co., Ltd. K1624975MP Monochrome LCD Monitor, RadiForce GX550, GX550-AREizo Corporation K1618952MP Color LCD Monitor CCL214 (CL21214)Jvckenwood Corporation K162196Dell UP3216Q with QUBYX PerfectLum bundleQubyx Software Technologies, Inc. K161057Diagnostic Imaging Color LCD MonitorNec Display Solutions , Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.