# K023053: Dyonics Vision 635 Image Management System

- Pathway: 510(k) (Special)
- Applicant: Smith & Nephew, Inc.
- Decided: Oct 3, 2002 after 20 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: 2 generations back to K000380 (2000). 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)
- K011944: Dyonics Vision 635 Digital Capture System, Model 7209088, Smith & Nephew, Inc. (2001)

## Indications for use
To capture intraoperative still and motion images.

Source page: https://510kreport.com/device/K023053
Methodology: https://510kreport.com/methodology