Yushan X-Ray Flat Panel Detector
K-Number: K250211 · 2025-07-22
ApplicantInnocare Optoelectronics Corp.
Decision Date2025-07-22
Product CodeMQB
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Yushan X-Ray Flat Panel Detector is a medical device manufactured by Innocare Optoelectronics Corp.. It received FDA 510(k) clearance on 2025-07-22 under approval number K250211. The device is classified under product code MQB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Yushan X-Ray Flat Panel Detector?
Yushan X-Ray Flat Panel Detector is a medical device that received FDA 510(k) clearance on 2025-07-22. It is manufactured by Innocare Optoelectronics Corp.. The 510(k) number is K250211.
When was Yushan X-Ray Flat Panel Detector approved by the FDA?
Yushan X-Ray Flat Panel Detector received FDA 510(k) clearance on 2025-07-22, under approval number K250211.
What company makes Yushan X-Ray Flat Panel Detector?
Yushan X-Ray Flat Panel Detector is manufactured by Innocare Optoelectronics Corp..
What is the FDA product code for Yushan X-Ray Flat Panel Detector?
The FDA product code for Yushan X-Ray Flat Panel Detector is MQB.
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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.