PerfusiX-Imaging— 510(k) K254180
Substantially EquivalentLIMIS Development B.V.
FDA 510(k) clearance K254180 for PerfusiX-Imaging, Substantially Equivalent on 2026-07-24. Applicant: LIMIS Development B.V.. Device class: 2.
Summary
PerfusiX-Imaging from LIMIS Development is filed under OWN, confocal optical imaging. The record doesn't describe what the system images or its components.
Class II, 21 CFR 876.1500. Gastroenterology and Urology is both the classification panel and the review panel, and it came in as a Traditional 510(k).
LIMIS Development filed from Leeuwarden, Netherlands. Review took 213 calendar days (December 23, 2025 to July 24, 2026).
Clearance details
- Applicant
- LIMIS Development B.V.
- Product code
- Product code OWN
- Device class
- Class 2
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Leeuwarden, NL
Recent devices under product code OWN
view allAdverse events under product code OWN
product code OWN- Malfunction
- 1,286
- Total
- 1,286
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.