# K241275: Histolog® Scanner  (Hardware 2.4, Software 3.3)

- Pathway: 510(k) (Traditional)
- Applicant: Samantree Medical SA
- Decided: Aug 19, 2024 after 105 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: 12 generations back to K935844 (1995). 79 ancestors in all.
No later device cites it as a predicate yet.
1 of 80 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K183640: Cellvizio 100 Series Confocal laser Imaging systems and their Confocal Miniprobes, Mauna Kea Technologies (2019) Summary page 4.

## Indications for use
The Histolog® Scanner is a confocal laser system 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.

Source page: https://510kreport.com/device/K241275
Methodology: https://510kreport.com/methodology