# K031433: Siemens Infinity Modular Monitors, Models SC 7000, SC 9000XL and SC 8000 with VF3 Modifications

- Pathway: 510(k) (Special)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Aug 19, 2003 after 105 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: 3 generations back to K946306 (1995). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K983632: Siemens SC 8000 Bedside Monitor, Siemens Medical Solutions USA, Inc. (1998) Summary page 1.
- K990563: Siemens SC 8000 Bedside Monitor with Advanced Communication Option, Siemens Medical Solutions USA, Inc. (1999) Summary page 1.
- K003243: Siemens Infinity Modular Monitors Model SC 8000; SC 7000; SC 9000XL, Siemens Medical Solutions USA, Inc. (2000) Summary page 1.
- K982730: SC 7000 & SC 9000 XL Infinity Modular Bedside Monitor, Siemens Medical Solutions USA, Inc. (1998) Summary page 1.
- K980882: Siemens  SC 7000 & SC 9000 XL Infinity Modular Bedside Monitor, Siemens Medical Solutions USA, Inc. (1998) Summary page 1.

## Indications for use
The INFINITY Modular monitors are capable of monitoring: Heart rate Respiration rate Invasive pressure Non-invasive pressure Arrhythmia Temperature Cardiac output Arterial oxygen saturation Pulse rate Apnea S T Segment Analysis 12-Lead S T Segment Analysis tcpo2/tcpco2 EEG signals Fi02 With the MultiCas and MultiGas+ modules the monitors arc capable of mcasuring respiration rate. Inspired and expired Carbon Dioxide (CO2), inspired and expired Oxygen (MultiGas+ only), averasc inspired Oxygen (MultiGas only), inspired and expired gas concentrations of Enflurane, Halothane, Isoflurane, Desflurane, Sevofluranc, and Nitrous Oxide. With ctC02 the monitors can nicasurc end tidal carhon dioxide, incpired carhon dioxide, and rcyxration rate in either mainstream or siclc-strcnm nieasurenicnt mode; and with etC02+Rcspiratory hlcchanics, spirometry and carbon dioxidc can he monitored. The monitors can interface with specific third party devices via an MIB protocol converter. The devices are 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 devices are intended to be used on Adult, Pediatric and Neonatal populations, with the exception of the parameter Cardiac Output, ST Segment Analysis, and arrhythmia which are intended for use in the adult and pediatric populations only; and tcp02 which is to be used in the neonatal population only when the patient is not under gas anesthesia. MRI Compatibility Statement: The INFINITY Modular Monitors are not compatible for use in a MRI magnetic field.

Source page: https://510kreport.com/device/K031433
Methodology: https://510kreport.com/methodology