# K180534: Philips IntelliVue GuardianSoftware

- Pathway: 510(k) (Traditional)
- Applicant: Philips Medizin Systeme Boeblingen GmbH
- Decided: Jul 16, 2018 after 138 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: 35 generations back to K941811 (1994). 267 ancestors in all.
2 later devices descend from it; 2 cite it directly.
2 of 270 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161767: Philips IntelliVue GuardianSoftware, Philips Medizin Systeme Boeblingen GmbH (2017) Summary page 5.

## Most influential descendants
- K212208: Philips IntelliVue GuardianSoftware (Rev. E.0X) (2021), 0 descendants of its own
- K202189: Graffiti (2020), 0 descendants of its own

## Indications for use
The IntelliVue GuardianSoftware is intended for use by healthcare providers whenever there is a need for generation of a patient record. The IntelliVue GuardianSoftware is indicated for use in the collection, storage and management of data from Philips specified measurements and Philips Patient Monitors that are connected through networks.

Source page: https://510kreport.com/device/K180534
Methodology: https://510kreport.com/methodology