iMac 27 & PL 4.0

FDA 510(k) K200889 · Quantum-Spectra, LLC

Substantially Equivalent

510(k) numberK200889

Submission

Device name
iMac 27 & PL 4.0
Applicant
Quantum-Spectra, LLC
Wilmington, DE, US
Received
April 3, 2020
Decision date
June 2, 2020
Decision
Substantially Equivalent (SESE)
Type
Traditional 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

Questions and answers

When was iMac 27 & PL 4.0 cleared by the FDA?

iMac 27 & PL 4.0 (K200889) received a 510(k) decision of Substantially Equivalent on June 2, 2020, 60 days after the submission was received.

What is the product code of K200889?

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