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FDA 510(k)

MammoSightAI

K-Number: K252954 · 2026-05-04

ApplicantNeurocareai, Inc. (Dba Savelife.Ai)
Decision Date2026-05-04
Product CodeQFM
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MammoSightAI is a medical device manufactured by Neurocareai, Inc. (Dba Savelife.Ai). It received FDA 510(k) clearance on 2026-05-04 under approval number K252954. 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 MammoSightAI?

MammoSightAI is a medical device that received FDA 510(k) clearance on 2026-05-04. It is manufactured by Neurocareai, Inc. (Dba Savelife.Ai). The 510(k) number is K252954.

When was MammoSightAI approved by the FDA?

MammoSightAI received FDA 510(k) clearance on 2026-05-04, under approval number K252954.

What company makes MammoSightAI?

MammoSightAI is manufactured by Neurocareai, Inc. (Dba Savelife.Ai).

What is the FDA product code for MammoSightAI?

The FDA product code for MammoSightAI is QFM.

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.

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