# K974492: Siemens SC6000/SC6000P Bedside Monitoring System Enhanced with ST Segment Analysis

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Feb 26, 1998 after 90 days
- Product code: MLD (Monitor, St Segment With Alarm)
- Device class: 2
- Regulation: 21 CFR 870.1025
- 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 K951371 (1995). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K951371: 1481 T Digital Telemetry System with S-T Segment Analysis Option, Siemens Medical Solutions USA, Inc. (1995) Summary page 1.

## Indications for use
The SC6000/SC6000P enhanced with ST Segment Analysis is intended to be used in the environment where patient care is provided by Healthcare Professionals, trained in the use of the device, i.e. physicians, nurses, and technicians, who will determine when use of ST Segment Analysis is indicated, based upon their professional assessment of the patient's medical condition. ST Segment Analysis is intended for use in the adult population. The SC6000/SC6000P is not for home use. The Siemens SC6000 / SC6000P Bedside Monitoring System is not compatible for use in a MRI magnetic field.

Source page: https://510kreport.com/device/K974492
Methodology: https://510kreport.com/methodology