Kortrijk, BE · 8 510(k) clearances · 4 recalls
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| PGY | Display, Diagnostic Radiology | Class II | Radiology | 4 | 2024-08-02 |
| PSN | Light Based Imaging | Class II | General, Plastic Surgery | 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 |
| Date | Severity | Status | Recall # | Product | Code | Reason |
|---|---|---|---|---|---|---|
| 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. |
| 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 | Class II | General, Plastic Surgery |
| 2021-04-15 | K203364 | MDPC-8127 | PSY | Class II | Pathology |
| 2021-02-18 | K201408 | Demetra Analytics Toolkit | PSN | Class II | General, Plastic Surgery |
| 2020-11-10 | K203106 | Nio Fusion 12MP (MDNC-12130) | PGY | Class II | Radiology |