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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 the device name listed in this FDA 510(k) record. The listed applicant is Lumea, Inc.. It received FDA 510(k) clearance on 2025-03-14 under 510(k) 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. The listed applicant is Lumea, Inc.. The 510(k) number is K242244.

When did Viewer+ receive FDA 510(k) clearance?

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

Who is the listed applicant for Viewer+?

The FDA 510(k) record lists Lumea, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Viewer+?

The FDA product code for Viewer+ is QKQ.

Related Devices (Code: QKQ)

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.

K253561Aperio iQC DX SoftwareLeica Biosystems Imaging, Inc.K261380Concentriq AP-DxProscia, Inc.K243449INFINITT DPSInfinitt Healthcare Co., Ltd.K252762HALO AP DxIndica Labs, LLCK243391AISight DxPathAI, Inc.K250968PathPresenter Clinical ViewerPathpresenter Corporation

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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