HSA · registration DE0510265GE Universal Viewer
- Registration number
- DE0510265
- Model name
- Universal Viewer
- Model identifier
- 00195278644039
- Registration date
- January 20, 2025
- Risk class
- Class B
- Product owner
- GE Healthcare
- Registrant / registration holder
- GE HEALTHCARE TECHNOLOGIES PACIFIC PRIVATE LIMITED
Universal Viewer is a software application that displays medical image data and associated clinical reports to aid in diagnosis for healthcare professionals. It performs operations relating to the transfer, storage, display, and measurement of image data. Typical users of this system are authorized healthcare professionals. Mammography images may only be interpreted using a monitor compliant with requirements of local regulations and must meet other technical specifications reviewed and accepted by the local regulatory agencies. Lossy compressed mammographic images and digitized film screen images should not be reviewed for primary image interpretations with use of the Universal Viewer.
- Product owner address
- 3000 N. Grandview Blvd, Waukesha, WI 53188, United States
- Registrant address
- 11 North Buona Vista Drive, #11-07, The Metropolis, Singapore 138589
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.