Nio Color 3MP (MDNC-3421)— 510(k) K170837

Substantially Equivalent

Barco N.V.

FDA 510(k) clearance K170837 for Nio Color 3MP (MDNC-3421), Substantially Equivalent on 2017-04-05. Applicant: Barco N.V.. Device class: 2.

Clearance details

Applicant: Barco N.V.
Product code: Code PGY
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2017-03-21
Decision date: 2017-04-05
Decision: Substantially Equivalent
Clearance type: Special
Location: Kortrijk, BE

Download summary PDF View on FDA.gov ↗

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Recalls naming K170837

K-number listed on FDA's recall record

Z-1172-2021 — Barco MDNC-3421 DISPLAY, DIAGNOSTIC RADIOLOGYClass II·Terminated·Barco N.V.·20210122

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K170837.

Data sourced from openFDA. This site is unofficial and independent of the FDA.