# K053412: Flexiscope, Models 50MH and 50 MHC

- Pathway: 510(k) (Traditional)
- Applicant: Schoelly Imaging, Inc.
- Decided: Feb 23, 2006 after 78 days
- Product code: FWF (Camera, Television, Endoscopic, Without Audio)
- Device class: 1
- Regulation: 21 CFR 878.4160
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K933868 (1993). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K933868: Angiolaz Video Endoscopic System Model CAMLUM1 and Accessories, Angiolaz, Inc. (1993) Summary page 1.

## Cited in the summary but kept off the family tree
- K940217: AMD Telemedicine AMD-300s Illumination & Imaging System. Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K090601: FSC 2 (2009), 0 descendants of its own

## Indications for use
The FlexiScope 5OMH / 5OMHC is indicated for use in conjunction with endoscopic devices to provide illumination and video visualization of optical images.

Source page: https://510kreport.com/device/K053412
Methodology: https://510kreport.com/methodology