FDA 510(k)

Red Dot

K-Number: K191556 · 2020-02-28

Decision Date2020-02-28

Product CodeQFM

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

Red Dot is the device name listed in this FDA 510(k) record. The listed applicant is Behold.Ai Technologies Limited. It received FDA 510(k) clearance on 2020-02-28 under 510(k) number K191556. 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 Red Dot?

Red Dot is a medical device that received FDA 510(k) clearance on 2020-02-28. The listed applicant is Behold.Ai Technologies Limited. The 510(k) number is K191556.

When did Red Dot receive FDA 510(k) clearance?

Red Dot received FDA 510(k) clearance on 2020-02-28, under 510(k) number K191556.

Who is the listed applicant for Red Dot?

The FDA 510(k) record lists Behold.Ai Technologies Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Red Dot?

The FDA product code for Red Dot 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.