# K031970: Infinity Megacare

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Sep 9, 2003 after 75 days
- Product code: DQK (Computer, Diagnostic, Programmable)
- Device class: 2
- Regulation: 21 CFR 870.1425
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K842308 (1984). 9 ancestors in all.
14 later devices descend from it; 2 cite it directly.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K980625: Siemens Multiview Workstation Enhanced with Diagnostic Statements (Rest Ecg), Siemens Medical Solutions USA, Inc. (1998) Summary page 1.
- K992637: Muse Cardiovascular Information System, General Electric Medical Systems Information Techn (1999) Summary page 1.
- K974420: M1730B Tracemaster Ecg System, M1766B Local Edit Station, M1798B Remote Edit Station, Hewlett-Packard Co. (1998) Summary page 1.
- K946281: Eclipse 4 Electrocardiograph, Burdick, Inc. (1996) Summary page 1.

## Most influential descendants
- K050858: Ascentia Heartstation Ecg Management System (2005), 13 descendants of its own
- K061905: Horizon Cardiology Ecg-Mckesson's Ecg Management System, Model 1.0 (2006), 8 descendants of its own
- K113515: Horizon Cardiology Ecg Management (2012), 7 descendants of its own
- K133534: Mckesson Cardiology Ecg Mobile (2014), 6 descendants of its own
- K151774: CARESTREAM Vue Motion (2015), 4 descendants of its own

## Indications for use
INmm MegaCare is a software application for viewing, manual editing, printing, and archiving of digitized electrocardiograph records from Rest ECG devices, Exercise ECG devices, Ambulance ECG devices, Holter ECG devices and the Infinity Monitoring System. INmm MegaCare is intended to provide analysis or reanalysis of Rest ECG’s and to provide preliminary data for editing and confirmation by a physician. INFINITY MegaCare can provide a serial comparison of Rest ECG data to facilitate the review of current and previous Rest ECG’s. INFINITY MegaCare is designed for network compatibility to facilitate retrieval of data and to interface with other hospital information systems though HL7 protocols. The device is intended for use in an environment where patient care is provided by Healthcare Professionals, i.e. physicians, nurses, and technicians, trained on the use of the device, who will determine when use of the device is indicated, based upon their professional assessment of the patient’s medical condition. The device is intended for use with all patient populations.

Source page: https://510kreport.com/device/K031970
Methodology: https://510kreport.com/methodology