# K254180: PerfusiX-Imaging

- Pathway: 510(k) (Traditional)
- Applicant: LIMIS Development B.V.
- Decided: Jul 24, 2026 after 213 days
- Product code: OWN (Confocal Optical Imaging)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 15 generations back to K930667 (1994). 73 ancestors in all.
No later device cites it as a predicate yet.
0 of 74 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K203550: ActivSight Intraoperative Imaging System, Activ Surgical, Inc. (2021) Summary page 5.

## Indications for use
PerfusiX-Imaging device is intended to be used only in combination with third party camera heads, rigid surgical endoscopes, monitors, accessories, and other ancillary equipment employed for surgical endoscopic diagnosis, treatment and video observation. PerfusiX-Imaging device enables real-time visual assessment of vessels, blood flow and related tissue perfusion by means of laser speckle contrast imaging (LSCI), during minimally invasive surgery (laparoscopy) of the gastrointestinal tract, using the device incorporated laser light illumination and video processor. The device is not intended for standalone use.

Source page: https://510kreport.com/device/K254180
Methodology: https://510kreport.com/methodology