FDA 510(k)

Orthopantomograph OP 3D

K-Number: K180947 · 2018-06-07

Decision Date2018-06-07

Product CodeOAS

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

Orthopantomograph OP 3D is a medical device manufactured by Palodex Group OY. It received FDA 510(k) clearance on 2018-06-07 under approval number K180947. The device is classified under product code OAS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Orthopantomograph OP 3D?

Orthopantomograph OP 3D is a medical device that received FDA 510(k) clearance on 2018-06-07. It is manufactured by Palodex Group OY. The 510(k) number is K180947.

When was Orthopantomograph OP 3D approved by the FDA?

Orthopantomograph OP 3D received FDA 510(k) clearance on 2018-06-07, under approval number K180947.

What company makes Orthopantomograph OP 3D?

Orthopantomograph OP 3D is manufactured by Palodex Group OY.

What is the FDA product code for Orthopantomograph OP 3D?

The FDA product code for Orthopantomograph OP 3D is OAS.

Other Devices by Palodex Group OY

K173646FS Ergo K163423Orthopantomograph OP300 K162799Cliniview K170813ORTHOPANTOMOGRAPH OP 3D K230505Orthopantomograph OP 3D LX K241249Orthopantomograph OP 3D LX (PAN 3D); Orthopantomograph OP 3D LX (PAN CEPH 3D)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.