Nio Color 5.8MP (MDNC-6121)

FDA 510(k) K170476 · Barco N.V.

Substantially Equivalent

510(k) numberK170476

Submission

Device name
Nio Color 5.8MP (MDNC-6121)
Applicant
Barco N.V.
Kortrijk, BE
Received
February 16, 2017
Decision date
March 28, 2017
Decision
Substantially Equivalent (SESE)
Type
Special 510(k)
Summary
510(k) statement 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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K233693Nio Color 8MP (MDNC-8132)PGY · Special 12/11/2023SE
K230520Nio Color 2MP (MDNC-2521); Nio Color 3MP (MDNC-3521)PGY · Special 03/21/2023SE
K213957Demetra Dermatoscope BDEM-01PSN · Special 03/11/2022SE
K203364MDPC-8127PSY · Traditional 04/15/2021SE
K201408Demetra Analytics ToolkitPSN · Traditional 02/18/2021SE
K203106Nio Fusion 12MP (MDNC-12130)PGY · Special 11/10/2020SE
K192829Demetra BDEM-01 DermatoscopePSN · Traditional 12/13/2019SE
K191845Coronis Fusion 6MP - MDCC-6530, Coronis Fusion 4MP - MDCC-4430, Intuitive Workflow Tools…PGY · Traditional 09/06/2019SE

Questions and answers

When was Nio Color 5.8MP (MDNC-6121) cleared by the FDA?

Nio Color 5.8MP (MDNC-6121) (K170476) received a 510(k) decision of Substantially Equivalent on March 28, 2017, 40 days after the submission was received.

What is the product code of K170476?

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