đź“‹ FDA Reference
Philips CS770 Intellispace Critical Care and Anesthesia
Philips Medical Systems
Summary: The Philips CS770 IntelliSpace is a critical care and anesthesia management system used by anesthesiologists and critical care specialists to monitor and manage patient data in intensive care settings.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K151366 ↗
Decision Date ?
October 30, 2015
Product Code ?
DXJ
Device Class ?
Class 2
Evidence ?
419 studies
The Philips CS770 IntelliSpace was cleared through the FDA 510k pathway on October 30, 2015. Manufactured by Philips Medical Systems, it is a Class 2 device under product code DXJ.
What It Is
The Philips CS770 IntelliSpace is an advanced software platform designed to integrate and manage patient data in critical care and anesthesia settings. It provides clinicians with real-time access to vital signs, lab results, and other critical information, facilitating informed decision-making. The system is designed to enhance workflow efficiency and improve patient outcomes by providing comprehensive data analysis and visualization tools.
FDA-Cleared Indications
- Intended for use in critical care and anesthesia environments to manage and display patient-related clinical information.
- Provides access to integrated patient data, which may include physiologic monitoring information and laboratory results, for use by healthcare professionals.
- Supports clinical information management for patients receiving critical care or anesthesia care.
Clinical Applications
- Managing and reviewing integrated patient information in intensive care units.
- Managing and reviewing clinical data during anesthesia care in operating-room settings.
- Displaying physiologic monitoring and laboratory information for critically ill patients.
- Supporting perioperative and postoperative clinical workflow through centralized patient-data access.
Practical Considerations
- This is a software and information-management system rather than an implanted, invasive, or standalone physiologic-monitoring device.
- Implementation depends on compatibility with the hospital's monitors, laboratory systems, electronic health record, network, and other information systems.
- The system should be configured, maintained, and validated according to the healthcare facility's policies and the manufacturer's instructions.
- It does not replace bedside assessment, source monitoring equipment, clinical judgment, or emergency-care procedures.
- No patient-contact size, vascular access requirement, or MRI labeling applies to the software platform itself; connected hardware must be evaluated separately for MRI compatibility.
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 CS770 IntelliSpace used for?
It is used for managing and monitoring patient data in critical care and anesthesia settings, providing real-time access to vital information.
What specialties typically use this device?
Anesthesiologists and critical care specialists primarily use this device in ICUs and ORs.
What are the FDA-cleared indications?
It is cleared for use in managing and monitoring patient data in critical care and anesthesia environments, particularly for critically ill patients or those undergoing major surgery.
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.