QGuideCT (1.0)— 510(k) K260523
Substantially EquivalentMedis Medical Imaging Systems BV
FDA 510(k) clearance K260523 for QGuideCT (1.0), Substantially Equivalent on 2026-10-05. Applicant: Medis Medical Imaging Systems BV. Device class: 2.
Summary
QGuideCT version 1.0 from Medis Medical Imaging Systems is filed under QIH, automated radiological image processing software. The "CT" in the name points to computed tomography images; the record doesn't describe the analysis it performs.
Class II, 21 CFR 892.2050. The Radiology panel reviewed it as a Traditional 510(k).
Medis filed from Leiden, the Netherlands. Review took 230 days (February 17 to October 5, 2026).
Clearance details
- Applicant
- Medis Medical Imaging Systems BV
- Product code
- Product code QIH
- Device class
- Class 2
- Regulation
- 21 CFR 892.2050
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Leiden, NL
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