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FDA 510(k)

MDPC-8127

K-Number: K203364 · 2021-04-15

ApplicantBarco N.V.
Decision Date2021-04-15
Product CodePSY
Advisory CommitteePA
DecisionSubstantially Equivalent

Device Summary

MDPC-8127 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 2021-04-15 under 510(k) number K203364. The device is classified under product code PSY. It was reviewed by the PA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MDPC-8127?

MDPC-8127 is a medical device that received FDA 510(k) clearance on 2021-04-15. The listed applicant is Barco N.V.. The 510(k) number is K203364.

When did MDPC-8127 receive FDA 510(k) clearance?

MDPC-8127 received FDA 510(k) clearance on 2021-04-15, under 510(k) number K203364.

Who is the listed applicant for MDPC-8127?

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 MDPC-8127?

The FDA product code for MDPC-8127 is PSY.

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.

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Related Devices (Code: PSY)

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.

K253554Aperio GT 450 DX; Aperio GT 180 DXLeica Biosystems Imaging, Inc.K260964NanoZoomer S540MD Slide Scanner SystemHamamatsu Photonics K.K.K251952VirasightVirasoft CorporationK253606NanoZoomer S20MD Slide scanner system; NanoZoomer S360MD Slide scanner systemHamamatsu Photonics K.K.K243871Philips IntelliSite Pathology Solution 5.1Philips Medical Systems Nederland B.V.K241717E1000 Dx Digital Pathology SolutionShandon Diagnostics Limited

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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