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510(k) Data Aggregation
K Number
K240890Device Name
PanopticAI Vital Signs
Manufacturer
PanopticAI Technologies Limited
Date Cleared
2024-12-23
(266 days)
Product Code
QME
Regulation Number
870.2785Why did this record match?
Applicant Name (Manufacturer) :
PanopticAI Technologies Limited
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The PanopticAl Vital Signs device is intended for noninvasive spot measurement of pulse rate when the subject is still. It is software for assessing facial video stream captured from a specified smartphone or tablet camera.
The PanopticAl Vital Signs device is intended for use by healthcare professionals. The device is only intended to be used in healthy subjects.
The PanopticAl Vital Signs device is indicated for use on humans 18 to 60 years of age who do not require critical care or continuous monitoring.
The PanopticAl Vital Signs device is not intended to be the sole method to assess a subject's physical health condition. The pulse rate measurements it provides should complement, not replace, professional medical care and/or medication.
Device Description
PanopticAl Vital Signs is a medical software device that uses remote photoplethysmography (rPPG) to measure a person's pulse rate. The app utilizes the surrounding light as the light source and works by capturing and measuring the subtle color changes on the skin caused by light absorption and reflection by the blood vessels beneath the skin. The app uses the front camera of an iPhone or iPad to capture videos of the subject. Then, the algorithm in the app detects and tracks the subject's face to capture the subtle light changes reflected in the changes in RGB pixel values. This information is sent to PanopticAl's cloud server for further processing to calculate the pulse rate. The pulse rate value is then returned to the PanopticAl Vital Signs app, and the result is displayed on the app.
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