# K233225: SCHOELLY Oxygen Saturation Imaging (OSI) Camera System (Camera Control Unit, Camera Head to be coupled to a fiberoptic scope)

- Pathway: 510(k) (Traditional)
- Applicant: Schoelly Fiberoptic GmbH
- Decided: Jun 20, 2024 after 266 days
- Product code: GCJ (Laparoscope, General & Plastic Surgery)
- 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: 19 generations back to K930667 (1994). 131 ancestors in all.
No later device cites it as a predicate yet.
3 of 132 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K203717: Processor VP-7000, Light Source BL-7000X, Image Processing Unit EX-0, Fujifilm Corporaton (2021) Summary page 6.
- K221591: Camera System (Camera Control Unit, Camera Head to be coupled to a fiberoptic scope), NIR FI Light Source, Schoelly Fiberoptic GmbH (2023) Summary page 7.

## Indications for use
The SCHOELLY Oxygen Saturation Imaging (OSI) Camera System (consisting of Camera Control Unit and Camera Head) is used for endoscopic observation, diagnosis, treatment, and image recording. It is intended to process signals transmitted from a fiberoptic endoscope that is connected to the Camera Head. This product may be used on all patients requiring endoscopic examination using SCHOELLY Laparoscopes and FUJIFILM's light source BL-7000X together with monitor, recorder and various peripheral devices. BLI (Blue Light Imaging) and LCI (Linked Color Imaging) are adjunctive tools which can be used to supplement white light endoscopy. BLI and LCI are not intended to replace histopathological sampling as a means of diagnosis. The SCHOELLY OSI Camera System is further intended for use as an adjunctive monitor of the hemoglobin oxygen saturation of blood in superficial tissue of the endoscopic observation image area in patients at risk for ischemic states. The prospective clinical value of measurements made with OSI has not been demonstrated in disease states.

Source page: https://510kreport.com/device/K233225
Methodology: https://510kreport.com/methodology