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FDA 510(k)

RadiForce RX570; RadiForce RX570-AR

K-Number: K243221 · 2024-11-27

Decision Date2024-11-27
Product CodePGY
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

RadiForce RX570; RadiForce RX570-AR is the device name listed in this FDA 510(k) record. The listed applicant is Eizo Corporation. It received FDA 510(k) clearance on 2024-11-27 under 510(k) number K243221. 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 RX570; RadiForce RX570-AR?

RadiForce RX570; RadiForce RX570-AR is a medical device that received FDA 510(k) clearance on 2024-11-27. The listed applicant is Eizo Corporation. The 510(k) number is K243221.

When did RadiForce RX570; RadiForce RX570-AR receive FDA 510(k) clearance?

RadiForce RX570; RadiForce RX570-AR received FDA 510(k) clearance on 2024-11-27, under 510(k) number K243221.

Who is the listed applicant for RadiForce RX570; RadiForce RX570-AR?

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 RX570; RadiForce RX570-AR?

The FDA product code for RadiForce RX570; RadiForce RX570-AR 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.