OptraSCAN System— 510(k) K260755

Substantially Equivalent

Optrascan, Inc.

FDA 510(k) clearance K260755 for OptraSCAN System, Substantially Equivalent on 2026-07-02. Applicant: Optrascan, Inc.. Device class: 2.

Clearance details

Applicant: Optrascan, Inc.
Product code: Code NOT
Device class: Class 2
Regulation: 21 CFR 864.1860
Advisory panel: Hematology
Date received: 2026-03-09
Decision date: 2026-07-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Jose, CA, 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.