# K001349: Cardiovise Ecg Interpretative Software

- Pathway: 510(k) (Traditional)
- Applicant: Inovise Medical, Inc.
- Decided: Jul 27, 2000 after 90 days
- Product code: MWJ (Electrocardiograph, Ambulatory (Without Analysis))
- Device class: 2
- Regulation: 21 CFR 870.2800
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
45 later devices descend from it; 1 cites it directly.
0 of 46 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
- K031182: Eli 200+ Audicor (2003), 44 descendants of its own
- K031517: Zargis Acoustic Cardioscan (2004), 19 descendants of its own
- K060197: Zargis Acoustic Cardioscan (Zac), Model Zac 6.28 (2006), 15 descendants of its own
- K083309: Zargis Acoustic Cardioscan, Version 9.33 (2009), 14 descendants of its own
- K110704: SENSI (2011), 13 descendants of its own

Source page: https://510kreport.com/device/K001349
Methodology: https://510kreport.com/methodology