# K970348: Siemens SC/9000/SC9015 Series Surgical Display Controller

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Aug 15, 1997 after 198 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.
293 later devices descend from it; 1 cites it directly.
0 of 295 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 2.

## Most influential descendants
- K013515: Infinity Explorer (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 Siemens SC9000/SC9015 Series Surgical Display Controller is indicated for use in an environment where patient care is provided by healthcare professionals (e.g. surgeons and other operating room personnel). It will be used whenever the professional determines that parameters and functions generated by the SC 9000/9015 Bedside Monitor should be displayed on a remote terminal.

Source page: https://510kreport.com/device/K970348
Methodology: https://510kreport.com/methodology