FDA 510(k)

VinDr-Mammo

K-Number: K233108 · 2024-05-23

Decision Date2024-05-23

Product CodeQFM

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

VinDr-Mammo is the device name listed in this FDA 510(k) record. The listed applicant is Vinbigdata Joint Stock Company. It received FDA 510(k) clearance on 2024-05-23 under 510(k) number K233108. The device is classified under product code QFM. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VinDr-Mammo?

VinDr-Mammo is a medical device that received FDA 510(k) clearance on 2024-05-23. The listed applicant is Vinbigdata Joint Stock Company. The 510(k) number is K233108.

When did VinDr-Mammo receive FDA 510(k) clearance?

VinDr-Mammo received FDA 510(k) clearance on 2024-05-23, under 510(k) number K233108.

Who is the listed applicant for VinDr-Mammo?

The FDA 510(k) record lists Vinbigdata Joint Stock Company as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VinDr-Mammo?

The FDA product code for VinDr-Mammo is QFM.

Related Devices (Code: QFM)

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.

K253751CXRDetectAINeurocareai, Inc. (Dba Savelife.Ai)K252954MammoSightAINeurocareai, Inc. (Dba Savelife.Ai)K252482CogNet AI-MT+Medcognetics, Inc.K250831Annalise EnterpriseAnnalise-Ai K243808Rayvolve PTX-PEAZmed K243548BriefCase-TriageAidoc Medical , Ltd.

Official Source

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