# K011944: Dyonics Vision 635 Digital Capture System, Model 7209088

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew, Inc.
- Decided: Sep 19, 2001 after 90 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: 1 generation back to K000380 (2000). 1 ancestor in all.
3 later devices descend from it; 3 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K000380: Fotomaster, Hamilton Thorne Research (2000)

## Most influential descendants
- K030728: Fyrelink VL (2003), 0 descendants of its own
- K023053: Dyonics Vision 635 Image Management System (2002), 0 descendants of its own
- K021236: Surgery and Accessories (2002), 0 descendants of its own

## Indications for use
The Dyonics Vision 635 Digital Capture System is indicated to be used in the operating room to digitally capture intra-operative still and motion images using the camera head, the foot switch, the front panel of the capture unit or the keyboard. Images are then stored in one of several standard image file formats on transportable media or to an Ethernet network for long term archival, retrieval or printing using third party image application software.

Source page: https://510kreport.com/device/K011944
Methodology: https://510kreport.com/methodology