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FDA 510(k)

RadiForce MX216

K-Number: K190153 · 2019-03-08

Decision Date2019-03-08
Product CodePGY
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

RadiForce MX216 is a medical device manufactured by Eizo Corporation. It received FDA 510(k) clearance on 2019-03-08 under approval number K190153. 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 MX216?

RadiForce MX216 is a medical device that received FDA 510(k) clearance on 2019-03-08. It is manufactured by Eizo Corporation. The 510(k) number is K190153.

When was RadiForce MX216 approved by the FDA?

RadiForce MX216 received FDA 510(k) clearance on 2019-03-08, under approval number K190153.

What company makes RadiForce MX216?

RadiForce MX216 is manufactured by Eizo Corporation.

What is the FDA product code for RadiForce MX216?

The FDA product code for RadiForce MX216 is PGY.

Other Devices by Eizo Corporation

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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.