# K060777: Smith & Nephew Model 660HD Image Management System

- Pathway: 510(k) (Special)
- Applicant: Smith & Nephew, Inc.
- Decided: Apr 13, 2006 after 22 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
No predicates in its family tree.
8 later devices descend from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Dyonics Vision 635 Image Management System: named in the summary without a submission number

## Most influential descendants
- K101734: Visionscope High Definition Endoscopy Camera System with; Camera Control Unit; Camera Handpiece; Visionscope Endoscopes (2010), 7 descendants of its own
- K153606: LENS Camera Control Unit-WiFi, LENS Camera Unit-Non-WiFi, LENS camera head, Camera Coupler, Tablet Application (2016), 6 descendants of its own
- K190367: Smith & Nephew Tablet Application (2019), 3 descendants of its own
- K192876: INTELLIO Tablet Application (2020), 2 descendants of its own
- K203566: Tablet Application (2021), 1 descendant of its own

## Indications for use
The Smith & Nephew 660HD Image Management System is intended to capture intraoperative still and motion images.

Source page: https://510kreport.com/device/K060777
Methodology: https://510kreport.com/methodology