VivoSight Dx Topical OCT System— 510(k) K153283

Name: FDA 510(k) clearance K153283
Creator: U.S. Food and Drug Administration
Published: 2016-08-11

Substantially Equivalent

Michelson Diagnostics, Ltd.

FDA 510(k) clearance K153283 for VivoSight Dx Topical OCT System, Substantially Equivalent on 2016-08-11. Applicant: Michelson Diagnostics, Ltd.. Device class: 2.

Clearance details

Applicant: Michelson Diagnostics, Ltd.
Product code: Code NQQ
Device class: Class 2
Regulation: 21 CFR 892.1560
Advisory panel: Radiology
Date received: 2015-11-12
Decision date: 2016-08-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Maidstone, GB

Download summary PDF View on FDA.gov ↗

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