SCANORA 3D— 510(k) K110839

Substantially Equivalent

Soredex Palodex Group OY

FDA 510(k) clearance K110839 for SCANORA 3D, Substantially Equivalent on 2011-06-30. Applicant: Soredex Palodex Group OY. Device class: 2.

Clearance details

Applicant: Soredex Palodex Group OY
Product code: Code OAS
Device class: Class 2
Regulation: 21 CFR 892.1750
Advisory panel: Radiology
Date received: 2011-03-25
Decision date: 2011-06-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tuusula, FI

Download summary PDF View on FDA.gov ↗

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