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510(k) Data Aggregation
K Number
K240756Device Name
AITRICS-VC
Manufacturer
AITRICS Co.,Ltd.
Date Cleared
2024-07-23
(125 days)
Product Code
PLB, MWI
Regulation Number
870.2300Why did this record match?
Applicant Name (Manufacturer) :
AITRICS Co.,Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The AITRICS-VC is stand-alone software intended to analyze patient data sourced from an EHR (Electronic Health Record) system and display data of in-hospital patient data whose vital signs, blood test results, or conventional early warning scores such as MEWS, and qSOFA exceed predefined thresholds. It is not intended to replace bedside patient monitors or clinical decision-making. It is not indicated for use in high-acuity environments like the ICU or operating rooms for acutely or critically ill patients. It may be used by clinicians to aid in understanding a patient's current condition and changes over time. The AITRICS-VC is solely indicated for use in the general ward of a hospital environment.
Device Description
AITRICS-VC is a clinical decision support software that receives in-hospital patient information, including physiological parameters such as vital signs and blood test results from EHR and conducts rule-based calculations for conventional early warning scores, which include NEWS (National Early Warning Score), MEWS (Modified Early Warning Score), and qSOFA (quickSOFA).
The AITRICS-VC screens patients who meet predefined criteria based on single values of physiological parameters and early warning scores. It displays a multi-patient dashboard and detailed pages for individual patients via a web browser on clinicians' PCs.
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