Karl Storz SE & CO. KG · Class II · Cleared Feb 12, 2026
| K-number | K253972 |
| Device name | IMAGE1 (TC400US); X-to-4U Adapter (TC040) |
| Applicant | Karl Storz SE & CO. KG |
| Product code | OWN |
| Device class | Class II |
| Decision date | Feb 12, 2026 |
| Decision | Substantially Equivalent |
| Regulation | 876.1500 |
The KARL STORZ IMAGE1 (TC400US) is a camera control unit (CCU) that provides real-time visible and near-infrared fluorescent imaging for endoscopic and microscopic procedures in adults and pediatrics. The X-to-4U Adapter allows connection of X-Line flexible videoendoscopes to the IMAGE1 CCU.
The IMAGE1 supports up to 4K-UHD resolution, brightness and enhancement controls (S-Clara, S-Chroma, SPECTRA A/B), automatic light source and shutter control, digital zoom (1x-2.5x), adaptive zoom, and multiple digital outputs (12G/3G-SDI, DisplayPort, DVI-D). It includes software application hosting capability, which the predicate device does not have.
IEC 60601-1 (electrical safety), IEC 60601-1-2 (EMC), IEC 60601-2-18 (endoscope safety), ISO 8600-3 (field of view testing), ISO 17664-2 (reprocessing), IEC 62304 (software life cycle), and FDA guidance on software validation.
Non-clinical bench testing demonstrated that the IMAGE1 is as safe and effective as the predicate KARL STORZ Image1S CCU (K233333) for white light and ICG fluorescent imaging performance, with comparable optical and functional characteristics. The addition of software application hosting does not raise new safety or effectiveness questions.
View the full FDA submission: accessdata.fda.gov