Viewer+— 510(k) K242244

Substantially Equivalent

Lumea, Inc.

FDA 510(k) clearance K242244 for Viewer+, Substantially Equivalent on 2025-03-14. Applicant: Lumea, Inc..

Clearance details

Applicant: Lumea, Inc.
Product code: Code QKQ
Advisory panel: Pathology
Date received: 2024-07-31
Decision date: 2025-03-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lehi, UT, US

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