SCANORA 3DX— 510(k) K130297

Substantially Equivalent

Palodex Group OY

FDA 510(k) clearance K130297 for SCANORA 3DX, Substantially Equivalent on 2013-05-29. Applicant: Palodex Group OY. Device class: 2.

Clearance details

Applicant: Palodex Group OY
Product code: Code OAS
Device class: Class 2
Regulation: 21 CFR 892.1750
Advisory panel: Radiology
Date received: 2013-02-06
Decision date: 2013-05-29
Decision: Substantially Equivalent
Clearance type: Special
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.