Orthopantomograph OP 3D LX (PAN 3D); Orthopantomograph OP 3D LX (PAN CEPH 3D)— 510(k) K241249

Name: FDA 510(k) clearance K241249
Creator: U.S. Food and Drug Administration
Published: 2024-09-12

Substantially Equivalent

Palodex Group OY

FDA 510(k) clearance K241249 for Orthopantomograph OP 3D LX (PAN 3D); Orthopantomograph OP 3D LX (PAN CEPH 3D), Substantially Equivalent on 2024-09-12. 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: 2024-05-03
Decision date: 2024-09-12
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.