Yushan X-Ray Flat Panel Detector with DROC
K-Number: K201528 · 2020-10-11
ApplicantInnocare Optoelectronics Corp.
Decision Date2020-10-11
Product CodeMQB
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Yushan X-Ray Flat Panel Detector with DROC is a medical device manufactured by Innocare Optoelectronics Corp.. It received FDA 510(k) clearance on 2020-10-11 under approval number K201528. 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 with DROC?
Yushan X-Ray Flat Panel Detector with DROC is a medical device that received FDA 510(k) clearance on 2020-10-11. It is manufactured by Innocare Optoelectronics Corp.. The 510(k) number is K201528.
When was Yushan X-Ray Flat Panel Detector with DROC approved by the FDA?
Yushan X-Ray Flat Panel Detector with DROC received FDA 510(k) clearance on 2020-10-11, under approval number K201528.
What company makes Yushan X-Ray Flat Panel Detector with DROC?
Yushan X-Ray Flat Panel Detector with DROC is manufactured by Innocare Optoelectronics Corp..
What is the FDA product code for Yushan X-Ray Flat Panel Detector with DROC?
The FDA product code for Yushan X-Ray Flat Panel Detector with DROC 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.