Chrysalis Intelligence · Sponsors · Barco N.V.

Barco N.V.

Kortrijk, BE · 8 510(k) clearances · 4 recalls

Total clearances
8
2020-11-10 → 2024-12-13
Last 12 months
0
Product codes
4
Most recent
2024-12-13
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
PGY Display, Diagnostic Radiology Class II Radiology 4 2024-08-02
PSN 2 2022-03-11
GCJ Laparoscope, General & Plastic Surgery Class II Gastroenterology, Urology 1 2024-12-13
PSY Whole Slide Imaging System Class II Pathology 1 2021-04-15
Safety

Recalls (4)

Class I (serious)
0
Risk of injury / death
Total recalls
4
Currently ongoing
2
Most recent
2025-05-09
DateSeverityStatusRecall # ProductCodeReason
2025-05-09 Class II Ongoing Z-1994-2025 Model: Description/REF: MNA-420: MNA-420 ENC -H/K9303320, MNA-420 DEC -H V2/K9303331; MNA-440: MNA-440 ENC -H/K9303300… Cathode ray tube display system encoders and decoders have same MAC address; new system setup with two or more affected units can lead to systems not functionin…
2024-04-24 Class II Completed Z-2332-2024 MNA-420 ENC HDMI, Material Number K9303311; cathode ray tube display We have identified a potential issue with the SFP+ module supplied by Molex (Part Number: B620050) when connected to the ETH0 slot of either the MNA-6x0 ENC HDM…
2023-12-20 Class II Ongoing Z-0979-2024 Barco MDSC-8527 NXF, Part Number K9352421 Barco became aware of a problem with I2C cables in the manufacturing process of a limited batch of MDSC-85xx NXF products. The functionality of the built-in MN…
2021-01-22 Class II Terminated Z-1172-2021 Barco MDNC-3421 DISPLAY, DIAGNOSTIC RADIOLOGY A number of MDNC-3421 displays were shipped while not being DICOM-compliant. These displays will not pass DICOM acceptance tests.
Filings

All 510(k) clearances (8)

Date K-number Device Code Class Specialty
2024-12-13 K243307 LCD Monitor (MDEC-2523) GCJ Class II Gastroenterology, Urology
2024-08-02 K242008 Coronis OneLook PGY Class II Radiology
2023-12-11 K233693 Nio Color 8MP (MDNC-8132) PGY Class II Radiology
2023-03-21 K230520 Nio Color 2MP (MDNC-2521); Nio Color 3MP (MDNC-3521) PGY Class II Radiology
2022-03-11 K213957 Demetra Dermatoscope BDEM-01 PSN
2021-04-15 K203364 MDPC-8127 PSY Class II Pathology
2021-02-18 K201408 Demetra Analytics Toolkit PSN
2020-11-10 K203106 Nio Fusion 12MP (MDNC-12130) PGY Class II Radiology