# Coronis Fusion 4MP (MDCC-4630); Coronis Fusion 6MP (MDCC-6630) (K262412): 510(k) cleared for Barco NV

**Predicate Speed & CAPA Advisory Opportunity Score:** 41/100

| Field | Value |
|---|---|
| Record | 510(k) clearance |
| 510(k) number | K262412 |
| Device | Coronis Fusion 4MP (MDCC-4630); Coronis Fusion 6MP (MDCC-6630) |
| Applicant | Barco NV |
| Specialty / panel | Radiology |
| Product code | PGY |
| Device class | 2 |
| Clearance type | Special |
| Decision | Substantially Equivalent |
| Received | 2026-07-15 |
| Decision date | 2026-10-02 |
| Review time (days) | 79 |
| Third-party review | No |
| Applicant location | Kortrijk, BE |

## Why this score
- Fast 79-day review: this device is a strong predicate for similar products.
- Special 510(k): a modification of an existing device.
- Posted 34 days ago.

Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262412). Last refreshed: 2026-11-04T09:16:12.111Z.
Data from the FDA openFDA API, which may lag official FDA databases. Informational only; not regulatory or legal advice.