RadiForce RX360, RX360-AR

FDA 510(k) K182591 · Eizo Corporation

Substantially Equivalent

510(k) numberK182591

Submission

Device name
RadiForce RX360, RX360-AR
Applicant
Eizo Corporation
Hakusan, JP
Received
September 20, 2018
Decision date
October 18, 2018
Decision
Substantially Equivalent (SESE)
Type
Abbreviated 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
PGY – Display, Diagnostic Radiology
Device class
Class II (moderate risk)
Regulation
21 CFR 892.2050
Specialty
Radiology

The device is intended for use in displaying radiological images for review, analysis, and diagnosis by trained medical practitioners.

Other 510(k)s with product code PGY

510(k)DeviceApplicantDecision
K262783RadiForce MX247WPGY · Abbreviated Eizo Corporation09/01/2026SE
K261213Medical Monitor (40HT513D)PGY · Traditional Lg Electronics.Inc06/12/2026SE
K252780LCD Monitor (CL1902A, CL2103F)PGY · Traditional Shenzhen Beacon Display Technology Co., Ltd.12/19/2025SE
K253242LCD Monitor (C1216W, C822W, C821W)PGY · Special Shenzhen Beacon Display Technology Co., Ltd.10/29/2025SE
K252030RadiForce GX570; RadiForce GX570-ARPGY · Abbreviated Eizo Corporation08/28/2025SE
K243221RadiForce RX570; RadiForce RX570-ARPGY · Abbreviated Eizo Corporation11/27/2024SE
K243031LCD Monitors C310S, G310S, C316S, G316S, C616WPGY · Special Shenzhen Beacon Display Technology Co., Ltd.10/25/2024SE
K242008Coronis OneLookPGY · Special Barco N.V.08/02/2024SE
K2411053MP Color LCD Monitor (CL-S301)PGY · Traditional Jvckenwood Corporation08/01/2024SE
K241441RadiForce RX670; RadiForce RX670-ARPGY · Abbreviated Eizo Corporation07/16/2024SE

More from Eizo Corporation

510(k)DeviceDecision
K262397CuratOR EX2742GCJ · Traditional 09/11/2026SE
K262783RadiForce MX247WPGY · Abbreviated 09/01/2026SE
K252030RadiForce GX570; RadiForce GX570-ARPGY · Abbreviated 08/28/2025SE
K242545RadiForce MX317W-PAPZZ · Abbreviated 05/23/2025SE
K243221RadiForce RX570; RadiForce RX570-ARPGY · Abbreviated 11/27/2024SE
K241441RadiForce RX670; RadiForce RX670-ARPGY · Abbreviated 07/16/2024SE
K233465RadiForce MX317WPGY · Abbreviated 12/21/2023SE
K231066CuratOR EX3242-FDGCJ · Traditional 12/18/2023SE
K230684RadiForce MX217PGY · Abbreviated 05/12/2023SE
K223768RadiForce RX270PGY · Abbreviated 04/20/2023SE

Questions and answers

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

RadiForce RX360, RX360-AR (K182591) received a 510(k) decision of Substantially Equivalent on October 18, 2018, 28 days after the submission was received.

What is the product code of K182591?

The FDA product code is PGY – Display, Diagnostic Radiology, a Class II (moderate risk) device regulated under 21 CFR 892.2050.