# K013515: Infinity Explorer

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Jan 10, 2002 after 80 days
- Product code: DXJ (Display, Cathode-Ray Tube, Medical)
- Device class: 2
- Regulation: 21 CFR 870.2450
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K900598 (1990). 8 ancestors in all.
292 later devices descend from it; 3 cite it directly.
0 of 301 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K970348: Siemens SC/9000/SC9015 Series Surgical Display Controller, Siemens Medical Solutions USA, Inc. (1997) Summary page 1.
- K955059: Olympus Comm. NTWK., SC 3000 WKST. & Remote Display, R 100 Recorder, Siemens Medical Solutions USA, Inc. (1996) Summary page 1.

## Most influential descendants
- 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
- K051106: The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue Patient Monitors (2005), 247 descendants of its own

## Indications for use
This device is capable of displaying physiological parameters received from INFINITY monitors (SC 7000, SC 8000, SC 9000XL) and visually displaying alarm data for those parameters. The device is capable of displaying DICOM images received over a hospital information system. The device is intended to be used in the environment where patient care is provided by Healthcare Professionals, i.e. physicians, nurses, and technicians, trained on the use of the device, 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 for use with the adult, pediatric and neonatal populatidns. MRI Compatibility Statement: The Siemens INFINITY EXPLORER is not compatible for use in a MRI magnetic field.

Source page: https://510kreport.com/device/K013515
Methodology: https://510kreport.com/methodology