FILM DIGITZER, MODEL 2908 MAMMO PRO— 510(k) K063424

Name: FDA 510(k) clearance K063424
Creator: U.S. Food and Drug Administration
Published: 2006-12-21

Substantially Equivalent

Array Corp.

FDA 510(k) clearance K063424 for FILM DIGITZER, MODEL 2908 MAMMO PRO, Substantially Equivalent on 2006-12-21. 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: 2006-11-13
Decision date: 2006-12-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tokyo, JP

Download summary PDF View on FDA.gov ↗

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