Orthopantomograph OP300
K-Number: K163423 · 2017-08-31
ApplicantPalodex Group OY
Decision Date2017-08-31
Product CodeOAS
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Orthopantomograph OP300 is a medical device manufactured by Palodex Group OY. It received FDA 510(k) clearance on 2017-08-31 under approval number K163423. 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 OP300?
Orthopantomograph OP300 is a medical device that received FDA 510(k) clearance on 2017-08-31. It is manufactured by Palodex Group OY. The 510(k) number is K163423.
When was Orthopantomograph OP300 approved by the FDA?
Orthopantomograph OP300 received FDA 510(k) clearance on 2017-08-31, under approval number K163423.
What company makes Orthopantomograph OP300?
Orthopantomograph OP300 is manufactured by Palodex Group OY.
What is the FDA product code for Orthopantomograph OP300?
The FDA product code for Orthopantomograph OP300 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.