Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) 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

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

Device Summary

RadiForce RX360, RX360-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 2018-10-18 under 510(k) 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. The listed applicant is Eizo Corporation. The 510(k) number is K182591.

When did RadiForce RX360, RX360-AR receive FDA 510(k) clearance?

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

Who is the listed applicant for RadiForce RX360, RX360-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 RX360, RX360-AR?

The FDA product code for RadiForce RX360, RX360-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.

K252030RadiForce GX570; RadiForce GX570-ARK242545RadiForce MX317W-PAK243221RadiForce RX570; RadiForce RX570-ARK241441RadiForce RX670; RadiForce RX670-ARK233465RadiForce MX317WK231066CuratOR EX3242-FD

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.

K261213Medical Monitor (40HT513D)Lg Electronics.IncK252780LCD Monitor (CL1902A, CL2103F)Shenzhen Beacon Display Technology Co., Ltd.K253242LCD Monitor (C1216W, C822W, C821W)Shenzhen Beacon Display Technology Co., Ltd.K252030RadiForce GX570; RadiForce GX570-AREizo CorporationK243221RadiForce RX570; RadiForce RX570-AREizo CorporationK243031LCD Monitors C310S, G310S, C316S, G316S, C616WShenzhen Beacon Display Technology Co., Ltd.

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.

↑