CW120N

FDA 510(k) K210491 · Wide Corporation

Substantially Equivalent

510(k) numberK210491

Submission

Device name
CW120N
Applicant
Wide Corporation
Hwaseong-Si, KR
Received
February 19, 2021
Decision date
April 8, 2021
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.

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More from Eizo Corporation

510(k)DeviceDecision
K222719CX50NPGY · Traditional 05/09/2023SE
K222716MX50NPGY · Traditional 05/08/2023SE
K222722CW60NPGY · Traditional 10/31/2022SE
K222717CL24NPGY · Traditional 10/31/2022SE
K210493CX30N (CX30PQX)PGY · Traditional 04/14/2021SE
K170781MX50N(MX50YQS)PGY · Traditional 04/04/2017SE
K170783CX50N(CX50YQS)PGY · Traditional 03/31/2017SE
K160354MX50T(MX50TQS)PGY · Traditional 05/02/2016SE
K160353MX50N(MX50YQS)PGY · Traditional 04/22/2016SE
K160348CX30N (CX30PQX)PGY · Traditional 04/14/2016SE

Questions and answers

When was CW120N cleared by the FDA?

CW120N (K210491) received a 510(k) decision of Substantially Equivalent on April 8, 2021, 48 days after the submission was received.

What is the product code of K210491?

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