Orthopantomograph OP 3D LX
K-Number: K230505 · 2023-06-09
ApplicantPalodex Group OY
Decision Date2023-06-09
Product CodeOAS
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Orthopantomograph OP 3D LX is a medical device manufactured by Palodex Group OY. It received FDA 510(k) clearance on 2023-06-09 under approval number K230505. 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?
Orthopantomograph OP 3D LX is a medical device that received FDA 510(k) clearance on 2023-06-09. It is manufactured by Palodex Group OY. The 510(k) number is K230505.
When was Orthopantomograph OP 3D LX approved by the FDA?
Orthopantomograph OP 3D LX received FDA 510(k) clearance on 2023-06-09, under approval number K230505.
What company makes Orthopantomograph OP 3D LX?
Orthopantomograph OP 3D LX is manufactured by Palodex Group OY.
What is the FDA product code for Orthopantomograph OP 3D LX?
The FDA product code for Orthopantomograph OP 3D LX is OAS.
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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.