# K083321: Cardio-View

- Pathway: 510(k) (Traditional)
- Applicant: Curlview Igt, LLC
- Decided: Nov 26, 2008 after 15 days
- Product code: DXJ (Display, Cathode-Ray Tube, Medical)
- Device class: 2
- Regulation: 21 CFR 870.2450
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K941811 (1994). 22 ancestors in all.
9 later devices descend from it; 4 cite it directly.
0 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073372: Electrophysiology Systems Integrator (Epsi), Systemsone (2007) Summary page 1.

## Most influential descendants
- K111320: Globalcardio (2011), 3 descendants of its own
- K122632: Guava II (2014), 2 descendants of its own
- K112645: Radiforce Large Monitor System (2011), 2 descendants of its own
- K172969: Essence 55S Large Monitor System (2018), 1 descendant of its own
- K162571: Bioflux Software (2016), 1 descendant of its own

## Indications for use
The Cardio-View system is intended to be used by health care professionals to integrate the video outputs from several commercially-available instruments commonly used in a medical procedure laboratory into a single video display. Control of the video sources is accomplished using a touchpad device.

Source page: https://510kreport.com/device/K083321
Methodology: https://510kreport.com/methodology