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FDA 510(k)

Focus 35C Detector, Trimax 35C Detector

K-Number: K192512 · 2019-10-16

ApplicantIray Technology Taicang , Ltd.
Decision Date2019-10-16
Product CodeMQB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Focus 35C Detector, Trimax 35C Detector is a medical device manufactured by Iray Technology Taicang , Ltd.. It received FDA 510(k) clearance on 2019-10-16 under approval number K192512. 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 35C Detector, Trimax 35C Detector?

Focus 35C Detector, Trimax 35C Detector is a medical device that received FDA 510(k) clearance on 2019-10-16. It is manufactured by Iray Technology Taicang , Ltd.. The 510(k) number is K192512.

When was Focus 35C Detector, Trimax 35C Detector approved by the FDA?

Focus 35C Detector, Trimax 35C Detector received FDA 510(k) clearance on 2019-10-16, under approval number K192512.

What company makes Focus 35C Detector, Trimax 35C Detector?

Focus 35C Detector, Trimax 35C Detector is manufactured by Iray Technology Taicang , Ltd..

What is the FDA product code for Focus 35C Detector, Trimax 35C Detector?

The FDA product code for Focus 35C Detector, Trimax 35C Detector is MQB.

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Related Devices (Code: 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.

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