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510(k) K191845

Coronis Fusion 6MP - MDCC-6530, Coronis Fusion 4MP - MDCC-4430, Intuitive Workflow Tools (IWT) by Barco N.V. — Product Code PGY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 6, 2019
Date Received
July 10, 2019
Clearance Type
Traditional
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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  • K213957 — Demetra Dermatoscope BDEM-01 (March 11, 2022)
  • K203364 — MDPC-8127 (April 15, 2021)
  • K201408 — Demetra Analytics Toolkit (February 18, 2021)
  • K203106 — Nio Fusion 12MP (MDNC-12130) (November 10, 2020)
  • K192829 — Demetra BDEM-01 Dermatoscope (December 13, 2019)
  • K173381 — Nexxis OR (February 22, 2018)

Other clearances for product code PGY

  • K252780 — LCD Monitor (CL1902A, CL2103F) (December 19, 2025)
  • K253242 — LCD Monitor (C1216W, C822W, C821W) (October 29, 2025)
  • K252030 — RadiForce GX570; RadiForce GX570-AR (August 28, 2025)
  • K243221 — RadiForce RX570; RadiForce RX570-AR (November 27, 2024)
  • K243031 — LCD Monitors C310S, G310S, C316S, G316S, C616W (October 25, 2024)
  • K242008 — Coronis OneLook (August 2, 2024)
  • K241105 — 3MP Color LCD Monitor (CL-S301) (August 1, 2024)
  • K241441 — RadiForce RX670; RadiForce RX670-AR (July 16, 2024)
  • K241499 — 21.3” 5MP Color LCD Display UMD5-21B01 (June 13, 2024)
  • K233336 — 21.3” 3MP Color LCD Display UMD3-21B01 (MD3-21B01) (May 21, 2024)