5MP Monochrome LCD Monitor MS55i2, 5MP Color LCD Monitor CCL550i2 (CL21550)

FDA 510(k) K160326 · Jvckenwood Corporation

Substantially Equivalent

510(k) numberK160326

Submission

Device name
5MP Monochrome LCD Monitor MS55i2, 5MP Color LCD Monitor CCL550i2 (CL21550)
Applicant
Jvckenwood Corporation
Yokohama, JP
Received
February 5, 2016
Decision date
February 23, 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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K1825392MP Color LCD Monitor CL-R211PGY · Traditional 10/03/2018SE
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Questions and answers

When was 5MP Monochrome LCD Monitor MS55i2, 5MP Color LCD Monitor CCL550i2 (CL21550) cleared by the FDA?

5MP Monochrome LCD Monitor MS55i2, 5MP Color LCD Monitor CCL550i2 (CL21550) (K160326) received a 510(k) decision of Substantially Equivalent on February 23, 2016, 18 days after the submission was received.

What is the product code of K160326?

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