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FDA 510(k)

RadiForce RX370

K-Number: K211491 · 2021-07-12

Decision Date2021-07-12
Product CodePGY
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

RadiForce RX370 is the device name listed in this FDA 510(k) record. The listed applicant is Eizo Corporation. It received FDA 510(k) clearance on 2021-07-12 under 510(k) number K211491. 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 RX370?

RadiForce RX370 is a medical device that received FDA 510(k) clearance on 2021-07-12. The listed applicant is Eizo Corporation. The 510(k) number is K211491.

When did RadiForce RX370 receive FDA 510(k) clearance?

RadiForce RX370 received FDA 510(k) clearance on 2021-07-12, under 510(k) number K211491.

Who is the listed applicant for RadiForce RX370?

The FDA 510(k) record lists Eizo Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RadiForce RX370?

The FDA product code for RadiForce RX370 is PGY.

Other records listing Eizo Corporation as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

View all 21 devices →

Related Devices (Code: PGY)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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.