Singapore HSA registration DE0506388
GE Universal Viewer
Singapore·CLASS B·GE Healthcare·Registered November 17, 2021Device classification
- Device Class
- CLASS B
- Medical Speciality Area
- Radiology / Imaging
Registration information
- Registration Number
- DE0506388
- Registration Date
- November 17, 2021
- Retention Due Date
- November 16, 2025
Product description
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
- Name
- GE Healthcare
- Short Name
- GE Healthcare
- Address
- 500 W. Monroe Street, Chicago, IL 60661, UNITED STATES
Registrant
- Address
- 11 NORTH BUONA VISTA DRIVE, THE METROPOLIS, #11-07, SINGAPORE 138589
Importer
- Address
- 11 NORTH BUONA VISTA DRIVE, THE METROPOLIS, #11-07, SINGAPORE 138589
Model information
- Model Name(s)
- Universal Viewer
- Model Identifier(s)
- 195278379610
About this record
Access comprehensive regulatory information for GE Universal Viewer in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0506388 and owned by GE Healthcare. The device was registered on November 17, 2021.
This page provides complete registration details including product owner information, registrant details, importer information, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA regulations efficiently.
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