Dental CT Scanner AXR— 510(k) K223816

Name: FDA 510(k) clearance K223816
Creator: U.S. Food and Drug Administration
Published: 2023-04-07

Substantially Equivalent

Alliage S/A Industrias Medico Odontológica

FDA 510(k) clearance K223816 for Dental CT Scanner AXR, Substantially Equivalent on 2023-04-07. Applicant: Alliage S/A Industrias Medico Odontológica. Device class: 2.

Clearance details

Applicant: Alliage S/A Industrias Medico Odontológica
Product code: Code OAS
Device class: Class 2
Regulation: 21 CFR 892.1750
Advisory panel: Radiology
Date received: 2022-12-20
Decision date: 2023-04-07
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Recreio Anhanguera, BR

Download summary PDF View on FDA.gov ↗

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