# K974352: Cardioview 3000 Software

- Pathway: 510(k) (Traditional)
- Applicant: Micromedical, Inc.
- Decided: Sep 8, 1998 after 293 days
- Product code: LOS
- 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; 2 cite 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. The FDA summary names its predicate without a number.
- (no number) MAX 1 Exercise Testing System: named in the summary without a submission number

## Most influential descendants
- K083749: CARDIOVIEW32 Review Module (2009), 9 descendants of its own
- K133988: Tempus Pro Extended Features (2014), 3 descendants of its own
- K170567: Tempus Pro Patient Monitor (2017), 2 descendants of its own
- K102378: Vectraplexecg System with Vectraplexami (2011), 2 descendants of its own
- K173952: Universal SmartECG (2018), 1 descendant of its own

## Indications for use
CARDIOVIEW™ 3000 interpretive software is a Windows-based program intended to interpret electrocardiograms. CARDIOVIEW™ 3000 interpretive software receives, displays and stores a single or standard 12-lead simultaneous ECG recording, which is transmitted either locally or transtelephonically from a Micromedical™ ECG monitor using a proprietary digital data transmission protocol. The device contains proprietary software algorithms to receive, store, analyze, and interpret the ECG signal.

Source page: https://510kreport.com/device/K974352
Methodology: https://510kreport.com/methodology