Philips Capsule Surveillance
- Registration number
- DE0509745
- Model name
- Capsule Surveillance
- Model identifier
- Capsule Surveillance
- Registration date
- September 06, 2024
- Risk class
- Class C
- Product owner
- Philips North America LLC
- Registrant / registration holder
- PHILIPS ELECTRONICS SINGAPORE PTE LTD
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.
- Product owner address
- 222 Jacobs Street, Cambridge, MA 02141, United States
- Registrant address
- 622 LORONG 1 TOA PAYOH, Singapore 319763
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.