# K083749: CARDIOVIEW32 Review Module

- Pathway: 510(k) (Special)
- Applicant: Qrs Diagnostic, LLC
- Decided: Mar 10, 2009 after 83 days
- Product code: LOS
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K974352 (1998). 1 ancestor in all.
9 later devices descend from it; 3 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K974352: Cardioview 3000 Software, Micromedical, Inc. (1998) Summary page 1.

## Most influential descendants
- 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
- K173768: Tempus Pro Patient Monitor (2018), 1 descendant of its own

## Indications for use
CardioView32 Review Module is a Window's based program intended to be called from a host application/database in a hospital or in a Physician's Office. CardioView32 Review Module receives, analyzes, displays, stores and prints ECG *.scp files generated from a standard 12-lead ECG recording. CardioView 32 Review Module provides interpretive statements for which the physician renders his/her own medical opinion. Patient Population: Male/Female, Adults Environment of Use: Hospital and Clinic Prescription Device by a Physician

Source page: https://510kreport.com/device/K083749
Methodology: https://510kreport.com/methodology