Focus 43C detector, TRIMAX 43C detector
K-Number: K200622 · 2020-04-01
ApplicantIray Technology Taicang , Ltd.
Decision Date2020-04-01
Product CodeMQB
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Focus 43C detector, TRIMAX 43C detector is a medical device manufactured by Iray Technology Taicang , Ltd.. It received FDA 510(k) clearance on 2020-04-01 under approval number K200622. 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 Focus 43C detector, TRIMAX 43C detector?
Focus 43C detector, TRIMAX 43C detector is a medical device that received FDA 510(k) clearance on 2020-04-01. It is manufactured by Iray Technology Taicang , Ltd.. The 510(k) number is K200622.
When was Focus 43C detector, TRIMAX 43C detector approved by the FDA?
Focus 43C detector, TRIMAX 43C detector received FDA 510(k) clearance on 2020-04-01, under approval number K200622.
What company makes Focus 43C detector, TRIMAX 43C detector?
Focus 43C detector, TRIMAX 43C detector is manufactured by Iray Technology Taicang , Ltd..
What is the FDA product code for Focus 43C detector, TRIMAX 43C detector?
The FDA product code for Focus 43C detector, TRIMAX 43C 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.