Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

RadiForce RX360, RX360-AR

K-Number: K182591 · 2018-10-18

Decision Date2018-10-18
Product CodePGY
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

RadiForce RX360, RX360-AR is a medical device manufactured by Eizo Corporation. It received FDA 510(k) clearance on 2018-10-18 under approval number K182591. 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 RX360, RX360-AR?

RadiForce RX360, RX360-AR is a medical device that received FDA 510(k) clearance on 2018-10-18. It is manufactured by Eizo Corporation. The 510(k) number is K182591.

When was RadiForce RX360, RX360-AR approved by the FDA?

RadiForce RX360, RX360-AR received FDA 510(k) clearance on 2018-10-18, under approval number K182591.

What company makes RadiForce RX360, RX360-AR?

RadiForce RX360, RX360-AR is manufactured by Eizo Corporation.

What is the FDA product code for RadiForce RX360, RX360-AR?

The FDA product code for RadiForce RX360, RX360-AR is PGY.

Other Devices by Eizo Corporation

View all 21 devices →

Related Devices (Code: PGY)

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.