Viewer+— 510(k) K242244

Substantially Equivalent

Lumea, Inc.

FDA 510(k) clearance K242244 for Viewer+, Substantially Equivalent on 2025-03-14. Applicant: Lumea, Inc.. Device class: 2.

Clearance details

Applicant: Lumea, Inc.
Product code: Code QKQ
Device class: Class 2
Regulation: 21 CFR 864.3700
Advisory panel: Pathology
Date received: 2024-07-31
Decision date: 2025-03-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lehi, UT, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.