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510(k) K171812

Nio Color 2MP (MDNC-2123) by Barco N.V. — Product Code PGY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 19, 2017
Date Received
June 19, 2017
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Display, Diagnostic Radiology
Device Class
Class II
Regulation Number
892.2050
Review Panel
RA
Submission Type

The device is intended for use in displaying radiological images for review, analysis, and diagnosis by trained medical practitioners.

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  • K192829 — Demetra BDEM-01 Dermatoscope (December 13, 2019)
  • K191845 — Coronis Fusion 6MP - MDCC-6530, Coronis Fusion 4MP - MDCC-4430, Intuitive Workfl (September 6, 2019)

Other clearances for product code PGY

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  • K243031 — LCD Monitors C310S, G310S, C316S, G316S, C616W (October 25, 2024)
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  • K241105 — 3MP Color LCD Monitor (CL-S301) (August 1, 2024)
  • K241441 — RadiForce RX670; RadiForce RX670-AR (July 16, 2024)
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