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.
Clearance details
- Applicant
- LIMIS Development B.V.
- Product code
- 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.