# K962260: Real-Time Video Contrast Enhancer

- Pathway: 510(k) (Traditional)
- Applicant: Digivision, Inc.
- Decided: Sep 9, 1996 after 89 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- 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 K864584 (1986). 1 ancestor in all.
10 later devices descend from it; 1 cites it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K864584: Fluorovision Contrast Enhancer, Digivision, Inc. (1986) Summary page 1.

## Most influential descendants
- K130929: Zmed VP4000 (2013), 9 descendants of its own
- K201434: Connected OR Hub with Voice Control, Connected OR Hub with Device Control (2020), 8 descendants of its own
- K212055: Connected OR Hub with Device and Voice Control (2021), 6 descendants of its own
- K220108: SDC4K Information Management System with Device and Voice Control Package (2022), 5 descendants of its own
- K222079: Connected OR Hub with Device and Voice Control, SDC4K Information Management System with Device and Voice Control (2022), 4 descendants of its own

## Indications for use
The CE-3000 Contrast Enhancer like the FluoroVision, may be used in any application where a viewing device (fluoroscope, endoscope, laparoscope, etc.) and monitor is incorporated to aid in diagnosis and treatment of a disease such as an arthroscopy or cholecystectomy. Despite the different indication statements, both devices have the same function and purpose and the differences in intended use does not create new safety or effectiveness issues.

Source page: https://510kreport.com/device/K962260
Methodology: https://510kreport.com/methodology