# K951130: Cardiosoft/Cardiosys

- Pathway: 510(k) (Traditional)
- Applicant: Marquette Electronics, Inc.
- Decided: Apr 4, 1996 after 388 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.
35 later devices descend from it; 3 cite it directly.
0 of 36 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) Hellige Cardiognost EK 512: named in the summary without a submission number

## Most influential descendants
- K973403: Cardiosmart ST (1998), 34 descendants of its own
- K991014: Case 8000 Exercise Testing System (1999), 33 descendants of its own
- K023380: T-Wave Altermans (Twa) Algorithm Option (2002), 31 descendants of its own
- K031561: Cardiosoft/Case Cardiac Testing System (2003), 30 descendants of its own
- K092010: PC Ecg, Model SE-1010 (2009), 18 descendants of its own

## Indications for use
CardioSoft / CardioSys are intended to be used in resting ECG, emergency- and stress-test departments to record, archive and disseminate ECG information. They are intended to be used by trained operators under the direct supervision of a physician when ECG records are required in the judgement of a physician.

Source page: https://510kreport.com/device/K951130
Methodology: https://510kreport.com/methodology