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FDA 510(k)

Koios DS for Breast

K-Number: K190442 · 2019-07-03

ApplicantKoios Medical, Inc.
Decision Date2019-07-03
Product CodePOK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Koios DS for Breast is a medical device manufactured by Koios Medical, Inc.. It received FDA 510(k) clearance on 2019-07-03 under approval number K190442. The device is classified under product code POK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Koios DS for Breast?

Koios DS for Breast is a medical device that received FDA 510(k) clearance on 2019-07-03. It is manufactured by Koios Medical, Inc.. The 510(k) number is K190442.

When was Koios DS for Breast approved by the FDA?

Koios DS for Breast received FDA 510(k) clearance on 2019-07-03, under approval number K190442.

What company makes Koios DS for Breast?

Koios DS for Breast is manufactured by Koios Medical, Inc..

What is the FDA product code for Koios DS for Breast?

The FDA product code for Koios DS for Breast is POK.

Other Devices by Koios Medical, Inc.

K212616Koios DS K242130Koios DS

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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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