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HSA · registration DE0509745

Philips Capsule Surveillance

SingaporeGeneral HospitalClass CPhilips North America LLC
Official record identity
Registration number
DE0509745
Model name
Capsule Surveillance
Model identifier
Capsule Surveillance
Registration date
September 06, 2024
Classification
Risk class
Class C
Official value: CLASS C
Published category
General Hospital
Published parties
Registrant / registration holder
PHILIPS ELECTRONICS SINGAPORE PTE LTD
Official description

Capsule Surveillance is a clinical decision support device that integrates, analyzes, and displays data from multiple sources including medical devices and healthcare information systems. It uses standardized rules that are based on customer-approved clinical practices, protocols, and policies to create clinically relevant alerts in health care facilities when used by clinical physicians or appropriate medical staff under the direction of physicians. It is not intended to replace clinicians’ judgment, but rather to assist clinicians in making timely, informed, higher quality decisions. Capsule Surveillance may be configured for secondary monitoring and alerting intended to be relied upon in deciding to take immediate clinical action. Capsule Surveillance may also be configured for remote display of physiological data and alerts not intended to be relied upon in deciding to take immediate clinical action.

Additional source fields
Product owner address
222 Jacobs Street, Cambridge, MA 02141, United States
Registrant address
622 LORONG 1 TOA PAYOH, Singapore 319763
About this record

This page mirrors one row from HSA’s official registered-medical-device workbook. Product owner and registrant are separate published roles; neither is relabeled as the manufacturer. The official NOT_GENERATED value is retained when HSA does not publish a registration number, and the device name remains part of the stable record identity.