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FDA 510(k)

Viewer+

K-Number: K242244 · 2025-03-14

ApplicantLumea, Inc.
Decision Date2025-03-14
Product CodeQKQ
Advisory CommitteePA
DecisionSubstantially Equivalent

Device Summary

Viewer+ is a medical device manufactured by Lumea, Inc.. It received FDA 510(k) clearance on 2025-03-14 under approval number K242244. The device is classified under product code QKQ. It was reviewed by the PA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Viewer+?

Viewer+ is a medical device that received FDA 510(k) clearance on 2025-03-14. It is manufactured by Lumea, Inc.. The 510(k) number is K242244.

When was Viewer+ approved by the FDA?

Viewer+ received FDA 510(k) clearance on 2025-03-14, under approval number K242244.

What company makes Viewer+?

Viewer+ is manufactured by Lumea, Inc..

What is the FDA product code for Viewer+?

The FDA product code for Viewer+ is QKQ.

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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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