SCANVIEW SYSTEM— 510(k) K110345

Substantially Equivalent

Applied Spectral Imaging

FDA 510(k) clearance K110345 for SCANVIEW SYSTEM, Substantially Equivalent on 2011-10-19. Applicant: Applied Spectral Imaging. Device class: 2.

Clearance details

Applicant: Applied Spectral Imaging
Product code: Code NTH
Device class: Class 2
Regulation: 21 CFR 866.4700
Advisory panel: Immunology
Date received: 2011-02-04
Decision date: 2011-10-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Haifa, IL

Download summary PDF View on FDA.gov ↗

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