# K251852: cCeLL - In vivo with Drop-In Robo (CN100-2W2C488775, CN100-1W1C775, DR200)

- Pathway: 510(k) (Traditional)
- Applicant: VPIX Medical, Inc.
- Decided: Feb 13, 2026 after 241 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: 21 generations back to K930667 (1994). 90 ancestors in all.
No later device cites it as a predicate yet.
0 of 91 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K220477: Cellvizio 100 series system with confocal Miniprobes, Mauna Kea Technologies (2022) Summary page 5.

## Indications for use
The cCeLL - In vivo with Drop-In Robo is a confocal laser system with fiber optic probe that are intended to allow imaging of the internal microstructure of tissues including, but not limited to, the identification of cells, vessels and their organization or architecture. Upon intravenous administration and use of an ICG consistent with its approved labeling, the cCeLL - In vivo with Drop-In Robo is used to perform fluorescence angiography. Upon administration and use of ICG consistent with its approved labeling, the cCeLL - In vivo with Drop-In Robo is used to perform fluorescence imaging to support the visual assessment of vessels, blood flow, and related tissue perfusion. The Drop-In Robo is intended to provide visualization of organs and canals during endoscopic and laparoscopic surgical procedures, including robot-assisted procedures.

Source page: https://510kreport.com/device/K251852
Methodology: https://510kreport.com/methodology