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FDA 510(k)

Mammo Tomosynthesis (MDMG-5221)

K-Number: K161229 · 2016-05-18

ApplicantBarco N.V.
Decision Date2016-05-18
Product CodePGY
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Mammo Tomosynthesis (MDMG-5221) is the device name listed in this FDA 510(k) record. The listed applicant is Barco N.V.. It received FDA 510(k) clearance on 2016-05-18 under 510(k) 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. The listed applicant is Barco N.V.. The 510(k) number is K161229.

When did Mammo Tomosynthesis (MDMG-5221) receive FDA 510(k) clearance?

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

Who is the listed applicant for Mammo Tomosynthesis (MDMG-5221)?

The FDA 510(k) record lists Barco N.V. as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Barco N.V. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K243307LCD Monitor (MDEC-2523)K242008Coronis OneLookK233693Nio Color 8MP (MDNC-8132)K230520Nio Color 2MP (MDNC-2521); Nio Color 3MP (MDNC-3521)K213957Demetra Dermatoscope BDEM-01K203364MDPC-8127

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Related Devices (Code: PGY)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261213Medical Monitor (40HT513D)Lg Electronics.IncK252780LCD Monitor (CL1902A, CL2103F)Shenzhen Beacon Display Technology Co., Ltd.K253242LCD Monitor (C1216W, C822W, C821W)Shenzhen Beacon Display Technology Co., Ltd.K252030RadiForce GX570; RadiForce GX570-AREizo CorporationK243221RadiForce RX570; RadiForce RX570-AREizo CorporationK243031LCD Monitors C310S, G310S, C316S, G316S, C616WShenzhen Beacon Display Technology Co., 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.

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