GENASIS SCANVIEW SYSTEM— 510(k) K122554

Name: FDA 510(k) clearance K122554
Creator: U.S. Food and Drug Administration
Published: 2013-02-07

Substantially Equivalent

Applied Spectral Imaging , Ltd.

FDA 510(k) clearance K122554 for GENASIS SCANVIEW SYSTEM, Substantially Equivalent on 2013-02-07. Applicant: Applied Spectral Imaging , Ltd.. Device class: 2.

Clearance details

Applicant: Applied Spectral Imaging , Ltd.
Product code: Code NTH
Device class: Class 2
Regulation: 21 CFR 866.4700
Advisory panel: Immunology
Date received: 2012-08-21
Decision date: 2013-02-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Caesarea, IL

Download summary PDF View on FDA.gov ↗

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