# K980882: Siemens  SC 7000 & SC 9000 XL Infinity Modular Bedside Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Jun 5, 1998 after 88 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 K946306 (1995). 1 ancestor in all.
309 later devices descend from it; 7 cite it directly.
0 of 311 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K946306: Siemens SC 9000 Bedside Monitor, SC 9015 Bedside Mointoring System, Siemens Medical Solutions USA, Inc. (1995) Summary page 1.

## Most influential descendants
- K012770: Infinity MICRO2+ (2002), 292 descendants of its own
- K022889: Siemens Infinity Modular Monitors, Models SC 8000, SC 7000 & SC 9000XL & Siemens Infinity Explorer (2002), 289 descendants of its own
- K031340: Siemens Infinity Modular Monitors, Models SC 8000, SC 7000 and SC 9000XL, with Scio (2003), 280 descendants of its own
- K041956: Emg - Essential Gas Module, Model M1013A (2004), 251 descendants of its own
- K050762: Philips Intellivue Patient Monitor, Models MP20, MP30, MP40, MP50, MP60, MP70 and MP90 (2005), 249 descendants of its own

## Indications for use
The SC 7000 and SC 9000XL INFINITY Modular Bedside monitors are capable of monitoring: Heart rate Respiration rate Invasive pressure Non-invasive pressure Arrhythmia Temperature Cardiac output Arterial oxygen saturation Puise rate End-tidal carbon dioxide (central) apnea ST segment analysis With the MultiGas™ and MultiGas+™ modules the SC 7000 and SC 9000XL are capable of measuring: Respiration rate {nspired and expired Carbon Dioxide (CO2) Inspired and expired Oxygen (MultiGas+™ only) Average inspired Oxygea (MultiGas™ only) Inspired and expired gas concentrations of Enflurane, Halothane, Isoflurane, Desflurane, Sevoflurane, and Nitrous Oxide. The SC 7000 and SC 9000XL can interface with third party devices. The devices are intended to be used in the environment where patient care is provided-by-Healthcare Professionals, i.c. 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 devices are 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 SC 7000 and SC 9000XL INFINITY Modular Bedside Monitors are not compatible for use in a MR1 magnetic field.

Source page: https://510kreport.com/device/K980882
Methodology: https://510kreport.com/methodology