# K981807: Cardiovision Software, Model S-CV5-96

- Pathway: 510(k) (Traditional)
- Applicant: Shl Telemedicine International, Ltd.
- Decided: Aug 19, 1998 after 90 days
- Product code: DPS (Electrocardiograph)
- Device class: 2
- Regulation: 21 CFR 870.2340
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K925639 (1993). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K955891: Cardioview Transtelephonic Software, Micromedical, Inc. (1996) Summary page 1.
- K925639: Cardiomagic Software, Instromedix, Inc. (1993) Summary page 1.

## Indications for use
VISUALIZATION AND MEASUREMENT OF ECG RECORDINGS TO BE USED BY TRAINED MEDICAL STAFF IN THE MONITORING OF CARDIAC CONDITION.

Source page: https://510kreport.com/device/K981807
Methodology: https://510kreport.com/methodology