2MP Color LCD Monitor CCL214 (CL21214)

FDA 510(k) K161895 · Jvckenwood Corporation

Substantially Equivalent

510(k) numberK161895

Submission

Device name
2MP Color LCD Monitor CCL214 (CL21214)
Applicant
Jvckenwood Corporation
Yokohama, JP
Received
July 11, 2016
Decision date
September 8, 2016
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

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K2411053MP Color LCD Monitor (CL-S301)PGY · Traditional 08/01/2024SE
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K2103452MP Monochrome LCD Monitor MS-S200PGY · Traditional 04/23/2021SE
K2001613MP Monochrome Digital Mammography LCD Monitor MS-S300PGY · Traditional 02/21/2020SE
K1911375MP Color LCD Monitor CL-S500, 5MP Monochrome LCD Monitor MS-S500PGY · Traditional 07/02/2019SE
K1825392MP Color LCD Monitor CL-R211PGY · Traditional 10/03/2018SE
K1734342MP Color LCD Monitor CL-S200, 3MP Color LCD Monitor CL-S300PGY · Traditional 12/14/2017SE
K1603265MP Monochrome LCD Monitor MS55i2, 5MP Color LCD Monitor CCL550i2 (CL21550)PGY · Traditional 02/23/2016SE

Questions and answers

When was 2MP Color LCD Monitor CCL214 (CL21214) cleared by the FDA?

2MP Color LCD Monitor CCL214 (CL21214) (K161895) received a 510(k) decision of Substantially Equivalent on September 8, 2016, 59 days after the submission was received.

What is the product code of K161895?

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