# K030615: Infinity Explorer

- Pathway: 510(k) (Special)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Mar 21, 2003 after 23 days
- Product code: MSX (System, Network And Communication, Physiological Monitors)
- Device class: 2
- Regulation: 21 CFR 870.2300
- 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 K900598 (1990). 9 ancestors in all.
31 later devices descend from it; 2 cite it directly.
0 of 41 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013515: Infinity Explorer, Siemens Medical Solutions USA, Inc. (2002)

## Most influential descendants
- K040945: Modification to Infinity Explorer (2004), 30 descendants of its own
- K042904: Infinity Kappa XLT (2005), 28 descendants of its own
- K060039: Infinity Delta and Kappa Series Monitors with VF6 Modifications (2006), 27 descendants of its own
- K070566: Infinity Delta/Delta XL/ Kappa/ Gamma X XL/ Vista XL/ SC7000/SC8000/ SC9000XL (2007), 26 descendants of its own
- K093788: Infinity Acute Care System (Iacs) Monitoring Solution (2010), 24 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 an 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 populations.

Source page: https://510kreport.com/device/K030615
Methodology: https://510kreport.com/methodology