📋 FDA Reference
Philips Intellivue Guardiansoftware Rev E 0x
Philips Medizin Systeme Boeblingen
Summary: The Philips IntelliVue GuardianSoftware Rev E 0x is a clinical decision support software used to monitor patient vitals and alert clinicians to potential deterioration. It is primarily used by healthcare professionals in hospital settings.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K212208 ↗
Decision Date ?
September 30, 2021
Product Code ?
DXJ
Device Class ?
Class 2
Evidence ?
419 studies
The Philips IntelliVue GuardianSoftware Rev E 0x was cleared through the FDA 510(k) pathway on September 30, 2021. It is manufactured by Philips Medizin Systeme Boeblingen and is classified as a Class 2 device under product code DXJ.
What It Is
The Philips IntelliVue GuardianSoftware Rev E 0x is a software solution designed to enhance patient monitoring by integrating with existing hospital systems. It continuously analyzes patient vital signs and other clinical data to provide early warning alerts to clinicians about potential patient deterioration. This proactive monitoring helps in timely intervention, potentially improving patient outcomes.
FDA-Cleared Indications
- For use by trained health care professionals as part of a clinical decision-support system.
- For analyzing patient-monitoring data and providing alerts or notifications that may support recognition of potential clinical deterioration.
- For use with compatible Philips IntelliVue monitoring and hospital information systems according to the manufacturer's labeling.
Clinical Applications
- Supporting surveillance of monitored patients in hospital settings.
- Analyzing available vital-sign or physiologic-monitoring data for clinically important changes.
- Providing alerts to clinicians for review and assessment of possible patient deterioration.
- Supporting clinical workflows in areas where patients are connected to compatible monitoring systems.
Practical Considerations
- This is software rather than an implanted or disposable device; it requires compatible monitoring hardware, software, network infrastructure, and hospital-system integration.
- Alerts support clinical assessment and do not replace examination, diagnostic testing, or clinician judgment.
- Hospitals should configure, test, update, and maintain the software according to Philips instructions and local information-technology policies.
- Staff should be trained to recognize, prioritize, and respond to alerts and to understand possible false-positive or missed alerts.
- MRI compatibility is not determined by the software alone; the connected monitors, accessories, network equipment, and local installation must be evaluated under the applicable Philips MRI and hospital protocols.
Linked Studies (20)
PubMed • 2025
Onyx Liquid Embolic Agent: Basic Knowledge for Its Use in Interventional Neuroradiology.
Journal of neuroendovascular therapy
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2025
Performance evaluation of quantitative hemoglobin A2 and fetal hemoglobin testing using commercially lyophilized vs. in-house whole blood controls in Chinese clinical laboratories: a 12-year analysis of National External Quality Assessment Data.
Clinical chemistry and laboratory medicine
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2025
Clinical progress note: Haemophilus influenzae type b.
Journal of hospital medicine
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2025
Pilot study of social media promotion of home-based self-testing for syphilis.
Sexually transmitted diseases
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2025
Clinical development and performance of the First to Know Syphilis Self-Test for over-the-counter usage: a de novo rapid test for treponemal antibody.
Journal of clinical microbiology
View Source →PubMed • 2025
Implementation of an Opt-Out and Rapid Point-of-Care Syphilis Testing Program for Pregnant Patients Presenting to the Emergency Department.
Sexually transmitted diseases
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2025
Evaluation of Rapid Syphilis Testing Using the Syphilis Health Check in Florida, 2015-2016.
Florida public health review
View Source →PubMed • 2025
Multiplex droplet digital PCR for the detection and quantitation of Streptococcus pneumoniae, Mycoplasma pneumoniae, and Haemophilus influenzae.
Frontiers in cellular and infection microbiology
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2025
Palm Multidiagnostic of Mycoplasma pneumoniae, Chlamydia pneumoniae, Haemophilus influenzae, and Streptococcus pneumoniae Using One-Tube CRISPR/Cas12a.
Transboundary and emerging diseases
View Source →PubMed • 2025
Tp40: a new potential prognostic and diagnostic marker for syphilis.
Microbiology spectrum
View Source →PubMed • 2025
Serotonin sets up neutrophil extracellular traps to promote neuroendocrine prostate cancer metastasis in the liver.
The Journal of clinical investigation
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2025
Application value of Philips Ingenuity TF PET/CT scanner imaging agent FAP in evaluating renal fibrosis.
Hellenic journal of nuclear medicine
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2025
Message from Dr. Philippe T. Georgel, Guest Editor for the Marshall University Collection, Brad D. Smith, President of Marshall University, and Dr. Anivandan Mukherjee, Provost of Marshall University.
Biochemistry and cell biology = Biochimie et biologie cellulaire
View Source →PubMed • 2025
Improved patient comfort and procedural efficiency using chlorhexidine-coated hydrophilic urethral catheters: a randomized controlled trial.
Journal of Yeungnam medical science
RCT View Source →PubMed • 2025
pTx-Pulseq in hybrid sequences: Accessible and advanced hybrid open-source MRI sequences on Philips scanners.
Magnetic resonance in medicine
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2025
Comparative connectomics of Drosophila descending and ascending neurons.
Nature
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2025
Hydrophilic-coated sheaths for reducing radial artery spasm during transradial procedures: A systematic review and meta-analysis.
Interventional neuroradiology : journal of peritherapeutic neuroradiology, surgical procedures and related neurosciences
View Source →PubMed • 2025
History of antineutrophil cytoplasmic autoantibodies : Milestones in rheumatology.
Zeitschrift fur Rheumatologie
View Source →PubMed • 2025
A Hydrophilic Polyurethane Foam Containing Nigella sativa Oil as a Wound Dressing.
BioMed research international
RCT|prospective|retrospective|case Series|other View Source →Frequently Asked Questions
What is Philips IntelliVue GuardianSoftware Rev E 0x used for?
It is used for continuous monitoring of patient vital signs and providing early warning alerts to clinicians about potential patient deterioration.
What specialties typically use this device?
Specialties such as critical care, internal medicine, and surgery often use this software in hospital settings.
What are the FDA-cleared indications?
The software is indicated for monitoring patient vitals and alerting clinicians to potential deterioration, aiding in timely intervention.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.