# K253972: IMAGE1 (TC400US); X-to-4U Adapter (TC040)

- Pathway: 510(k) (Traditional)
- Applicant: Karl Storz SE & CO. KG
- Decided: Feb 12, 2026 after 63 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). 122 ancestors in all.
No later device cites it as a predicate yet.
0 of 123 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K233333: KARL STORZ ICG Imaging System, KARL STORZ Image1S Camera Control Unit, Karl Storz SE & CO. KG (2023) Summary page 5.

## Indications for use
The IMAGE1, a camera control unit (CCU), when used with compatible camera heads or videoendoscopes and ancillary equipment, is intended to provide real-time visible (VIS) and near-infrared (NIR) fluorescent imaging and documentation of endoscopic and microscopic procedures in adults and pediatrics. The X-to-4U Adapter, as ancillary equipment, is intended to connect compatible camera heads or videoendoscopes to the IMAGE1 CCU.

Source page: https://510kreport.com/device/K253972
Methodology: https://510kreport.com/methodology