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FDA 510(k)

Orthopantomograph™ OP 3D LX (PAN 3D); Orthopantomograph™ OP 3D LX (PAN CEPH 3D)

K-Number: K241249 · 2024-09-12

ApplicantPalodex Group OY
Decision Date2024-09-12
Product CodeOAS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Orthopantomograph™ OP 3D LX (PAN 3D); Orthopantomograph™ OP 3D LX (PAN CEPH 3D) is a medical device manufactured by Palodex Group OY. It received FDA 510(k) clearance on 2024-09-12 under approval number K241249. 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 LX (PAN 3D); Orthopantomograph™ OP 3D LX (PAN CEPH 3D)?

Orthopantomograph™ OP 3D LX (PAN 3D); Orthopantomograph™ OP 3D LX (PAN CEPH 3D) is a medical device that received FDA 510(k) clearance on 2024-09-12. It is manufactured by Palodex Group OY. The 510(k) number is K241249.

When was Orthopantomograph™ OP 3D LX (PAN 3D); Orthopantomograph™ OP 3D LX (PAN CEPH 3D) approved by the FDA?

Orthopantomograph™ OP 3D LX (PAN 3D); Orthopantomograph™ OP 3D LX (PAN CEPH 3D) received FDA 510(k) clearance on 2024-09-12, under approval number K241249.

What company makes Orthopantomograph™ OP 3D LX (PAN 3D); Orthopantomograph™ OP 3D LX (PAN CEPH 3D)?

Orthopantomograph™ OP 3D LX (PAN 3D); Orthopantomograph™ OP 3D LX (PAN CEPH 3D) is manufactured by Palodex Group OY.

What is the FDA product code for Orthopantomograph™ OP 3D LX (PAN 3D); Orthopantomograph™ OP 3D LX (PAN CEPH 3D)?

The FDA product code for Orthopantomograph™ OP 3D LX (PAN 3D); Orthopantomograph™ OP 3D LX (PAN CEPH 3D) is OAS.

Other Devices by Palodex Group OY

K173646FS Ergo K163423Orthopantomograph OP300 K162799Cliniview K170813ORTHOPANTOMOGRAPH OP 3D K180947Orthopantomograph OP 3D K230505Orthopantomograph™ OP 3D LX

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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.

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