# K090601: FSC 2

- Pathway: 510(k) (Traditional)
- Applicant: Schoelly Imaging, Inc.
- Decided: May 11, 2009 after 67 days
- Product code: NTN (Led Light Source)
- 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: 2 generations back to K933868 (1993). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K053412: Flexiscope, Models 50MH and 50 MHC, Schoelly Imaging, Inc. (2006) Summary page 1.

## Indications for use
The FSC 2 is intended to be used in conjunction with endoscopic devices to provide illumination and video visualization of optical images to visualize and observe body spaces.

Source page: https://510kreport.com/device/K090601
Methodology: https://510kreport.com/methodology