# QGuideCT (1.0) (K260523): 510(k) cleared for Medis Medical Imaging Systems BV

**Predicate Speed & CAPA Advisory Opportunity Score:** 48/100

| Field | Value |
|---|---|
| Record | 510(k) clearance |
| 510(k) number | K260523 |
| Device | QGuideCT (1.0) |
| Applicant | Medis Medical Imaging Systems BV |
| Specialty / panel | Radiology |
| Product code | QIH |
| Device class | 2 |
| Clearance type | Traditional |
| Decision | Substantially Equivalent |
| Received | 2026-02-17 |
| Decision date | 2026-10-05 |
| Review time (days) | 230 |
| Third-party review | No |
| Applicant location | Leiden, NL |

## Why this score
- 230-day review, longer than typical.
- Posted 30 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=K260523). 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.