# K864584: Fluorovision Contrast Enhancer

- Pathway: 510(k) (Traditional)
- Applicant: Digivision, Inc.
- Decided: Dec 29, 1986 after 39 days
- Product code: JAA (System, X-Ray, Fluoroscopic, Image-Intensified)
- Device class: 2
- Regulation: 21 CFR 892.1650
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
11 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)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K962260: Real-Time Video Contrast Enhancer (1996), 10 descendants of its own
- 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

Source page: https://510kreport.com/device/K864584
Methodology: https://510kreport.com/methodology