IntelliVue GuardianSoftware (Rev. E.0X)
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K212208 FDA 510(k)
- FDA Product Code
- DXJ FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.2450 FDA 510(k)
- Regulation Number
- 870.2450 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
IntelliVue GuardianSoftware (Rev. E.0X) is a software application for medical display and monitoring, designed to process and visualize patient data from connected medical devices. It functions as a centralized platform for real-time cardiac monitoring, enabling healthcare providers to analyze and manage vital signs, electrocardiograms (ECGs), and other physiological parameters in clinical settings.
The software is intended for use in hospital and critical care environments, where it interfaces with compatible Philips monitoring systems to aggregate and display patient data. Supplied as a non-sterile, reusable digital solution, it operates within regulatory frameworks including FDA 510(k) clearance and MDR compliance. No specific MRI safety classification is noted, and its functionality relies on integration with authorized hardware platforms, ensuring adherence to medical device standards for cardiovascular monitoring.
Frequently asked questions
What clinical environments is the Philips IntelliVue GuardianSoftware (Rev. E.0X) designed to support, and how does it integrate with existing systems?
The Philips IntelliVue GuardianSoftware (Rev. E.0X) is specifically designed for hospital and critical care settings, where real-time cardiac monitoring is essential. It functions as a centralized platform to process and visualize patient data—such as vital signs, electrocardiograms (ECGs), and other physiological parameters—from compatible Philips monitoring systems. The software relies on integration with authorized Philips hardware platforms to aggregate and display this data, ensuring seamless operation within cardiovascular-focused clinical workflows.
Is the Philips IntelliVue GuardianSoftware (Rev. E.0X) a single-use or reusable solution, and what are its sterility requirements?
The Philips IntelliVue GuardianSoftware (Rev. E.0X) is a reusable digital software application, not a physical consumable. As a non-sterile solution, it does not require sterilization procedures. However, the hardware it interfaces with (e.g., monitoring systems) may have their own sterility or cleaning protocols, which should be followed as per manufacturer guidelines for those devices.
What regulatory pathways does the Philips IntelliVue GuardianSoftware (Rev. E.0X) follow, and how does this affect its use in clinical settings?
The Philips IntelliVue GuardianSoftware (Rev. E.0X) has undergone FDA 510(k) clearance and complies with MDR (Medical Device Regulation) standards, confirming its adherence to safety and performance requirements. This regulatory route ensures the software meets U.S. and EU standards for cardiovascular monitoring systems, allowing clinicians to rely on its accuracy and integration with authorized Philips hardware platforms in clinical settings.
Does the Philips IntelliVue GuardianSoftware (Rev. E.0X) have any specific compatibility requirements with other medical devices?
Yes, the Philips IntelliVue GuardianSoftware (Rev. E.0X) is intended for use exclusively with compatible Philips monitoring systems. Its functionality depends on integration with authorized hardware platforms, ensuring seamless data processing, visualization, and management of patient vitals—particularly cardiac parameters—in clinical environments. Always verify compatibility with the specific Philips hardware in use.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Philips Deutschland – Wikipedia
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K212208 | Class II | Active |
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Manufacturer
- Manufacturer
- Philips Medizin Systeme Boeblingen GmbH
Sources (2)
- FDA 510(k) K212208 24 fields · synced Oct 6, 2026
- EUDAMED 1 fields · synced May 18, 2026