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FDA 510(k)

RadiForce MX194

K-Number: K180961 · 2018-05-10

Decision Date2018-05-10
Product CodePGY
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

RadiForce MX194 is a medical device manufactured by Eizo Corporation. It received FDA 510(k) clearance on 2018-05-10 under approval number K180961. The device is classified under product code PGY. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RadiForce MX194?

RadiForce MX194 is a medical device that received FDA 510(k) clearance on 2018-05-10. It is manufactured by Eizo Corporation. The 510(k) number is K180961.

When was RadiForce MX194 approved by the FDA?

RadiForce MX194 received FDA 510(k) clearance on 2018-05-10, under approval number K180961.

What company makes RadiForce MX194?

RadiForce MX194 is manufactured by Eizo Corporation.

What is the FDA product code for RadiForce MX194?

The FDA product code for RadiForce MX194 is PGY.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.