CAPIMAGE— 510(k) K081829

Substantially Equivalent

Danish Diagnostic Development A/S

FDA 510(k) clearance K081829 for CAPIMAGE, Substantially Equivalent on 2008-07-11. Applicant: Danish Diagnostic Development A/S. Device class: 1.

Clearance details

Applicant: Danish Diagnostic Development A/S
Product code: Code IYX
Device class: Class 1
Regulation: 21 CFR 892.1100
Advisory panel: Radiology
Date received: 2008-06-27
Decision date: 2008-07-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Horsholm, DK

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.