K254180
- 510(k) number
- K254180
- Device name
- PerfusiX-Imaging
- Applicant
- LIMIS Development B.V. NL
- Product code
- OWN — Confocal Optical Imaging
- Decision date
- 2026-07-24
- Date received
- 2025-12-23
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K254180.pdf
Official FDA record: K254180
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.