Dental CBCT X-ray System
K-Number: K251642 · 2025-06-27
Decision Date2025-06-27
Product CodeOAS
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Dental CBCT X-ray System is a medical device manufactured by Yian Medical Technology (Haining) Co., Ltd.. It received FDA 510(k) clearance on 2025-06-27 under approval number K251642. 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 Dental CBCT X-ray System?
Dental CBCT X-ray System is a medical device that received FDA 510(k) clearance on 2025-06-27. It is manufactured by Yian Medical Technology (Haining) Co., Ltd.. The 510(k) number is K251642.
When was Dental CBCT X-ray System approved by the FDA?
Dental CBCT X-ray System received FDA 510(k) clearance on 2025-06-27, under approval number K251642.
What company makes Dental CBCT X-ray System?
Dental CBCT X-ray System is manufactured by Yian Medical Technology (Haining) Co., Ltd..
What is the FDA product code for Dental CBCT X-ray System?
The FDA product code for Dental CBCT X-ray System 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.