MEDICAL IMAGE DIGITIZER, MODEL 2908— 510(k) K033637

Name: FDA 510(k) clearance K033637
Creator: U.S. Food and Drug Administration
Published: 2003-12-17

Substantially Equivalent

Array Corp.

FDA 510(k) clearance K033637 for MEDICAL IMAGE DIGITIZER, MODEL 2908, Substantially Equivalent on 2003-12-17. Applicant: Array Corp.. Device class: 2.

Clearance details

Applicant: Array Corp.
Product code: Code LMA
Device class: Class 2
Regulation: 21 CFR 892.2030
Advisory panel: Radiology
Date received: 2003-11-19
Decision date: 2003-12-17
Decision: Substantially Equivalent
Clearance type: Special
Location: Shibuya-Ku, Tokyo, JP

Download summary PDF View on FDA.gov ↗

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