OptosAdvance 4.0 Software— 510(k) K162039

Substantially Equivalent

Optos Plc.

FDA 510(k) clearance K162039 for OptosAdvance 4.0 Software, Substantially Equivalent on 2017-02-08. Applicant: Optos Plc.. Device class: 2.

Clearance details

Applicant: Optos Plc.
Product code: Code NFJ
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2016-07-22
Decision date: 2017-02-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dunfermline, GB

Download summary PDF View on FDA.gov ↗

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