Focus HD 35 Detector
K-Number: K213646 · 2022-03-29
ApplicantIray Technology Taicang , Ltd.
Decision Date2022-03-29
Product CodeMQB
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Focus HD 35 Detector is a medical device manufactured by Iray Technology Taicang , Ltd.. It received FDA 510(k) clearance on 2022-03-29 under approval number K213646. 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 HD 35 Detector?
Focus HD 35 Detector is a medical device that received FDA 510(k) clearance on 2022-03-29. It is manufactured by Iray Technology Taicang , Ltd.. The 510(k) number is K213646.
When was Focus HD 35 Detector approved by the FDA?
Focus HD 35 Detector received FDA 510(k) clearance on 2022-03-29, under approval number K213646.
What company makes Focus HD 35 Detector?
Focus HD 35 Detector is manufactured by Iray Technology Taicang , Ltd..
What is the FDA product code for Focus HD 35 Detector?
The FDA product code for Focus HD 35 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.