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GE Universal Viewer - HSA Registration DE0510265

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 DE0510265 and owned by GE Healthcare. The device was registered on January 20, 2025.

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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CLASS B
DE0510265
GE Universal Viewer
HSA Registration Number: DE0510265
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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.

Device Classification
Device Class
CLASS B
Medical Speciality Area
Radiology / Imaging
Registration Information
Registration Number
DE0510265
Registration Date
January 20, 2025
Retention Due Date
January 19, 2026
Product Owner
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)
195278644039