# K974698: Siemens SC9000/SC9015 Enhanced with 12-Lead ST Segment Analysis

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Jul 8, 1998 after 204 days
- Product code: DSI (Detector And Alarm, Arrhythmia)
- 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 K915225 (1992). 1 ancestor in all.
8 later devices descend from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K915225: Megacart, Siemens Burdick, Inc. (1992) Summary page 2.

## Most influential descendants
- K030738: Siemens Multiview Infinity Telemetry System (2003), 7 descendants of its own
- K060307: 12 RL Algorithm (2006), 5 descendants of its own
- K101521: ST/AR ST and Arrhythmia Software Model: Release K.O (2010), 4 descendants of its own
- K150352: V Series Monitoring System (including V12 and V21 Monitors) (2015), 1 descendant of its own
- K153448: Passport Series Patient Monitors (Including Passport 8, Passport 12) (2016), 0 descendants of its own

## Indications for use
This device is capable of monitoring . Heart rate = Resprration rale . Invasive pressure . Non-invasive pressure . Arrhythmia Temperature . Cardiac output . Arterial oxygen saturation Pulse rate . End-tidal carbon dioxide (central) apnea ST segment analysis With the MultiGas™ and MultiGas+™ modules the SC3000/SC9015 is capable of measuring: . Respiration rate . Inspired and expired Carbon Dioxide (CO2) . Inspired and expired Oxygen (MultiGas+™ only) . Average inspired Oxygen (MultiGas™ only) . Inspired and expired gas concentrations of Enflurane, Halothane, Isoflurane, Desflurane, Sevoflurane, and Nitrous Oxide. The SC9000/SC9015 is capable of performing 12-lead ST Segment analysis. This device can be connected to third party devices: Siemens SV300™ ventilator, the Baxter Vigilance™ blood gas/continuous cardiac output monitor, Puritan Bennett 7200™, Dräger Evita II™, Evita V™ & Babylog™, and Siemens SV900™ ventilators. The device is intended to be used in the environment where patient care is provided by Healthcare Professionals, i.e. Physicians, Nurses, and Technicians, 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 to be used on Adult, Pediatric and Neonatal populations, with the exception of the parameter Cardiac Output and ST Segment Analysis which are intended for use in the adult and pediatric populations only; and Arrhythmia which is intended for use in the adult population only MRI Compatibility Statement: The Siemens SC9000/SC9015 Bedside Monitoring System Enhanced with 12-Lead ST Segment Analysis is not compatible for use in a MRI magnetic field.

Source page: https://510kreport.com/device/K974698
Methodology: https://510kreport.com/methodology