Singapore HSA registration DE0504619
GE Centricity PACS
Device classification
- Device Class
- CLASS B
- Medical Speciality Area
- Radiology / Imaging
Registration information
- Registration Number
- DE0504619
- Registration Date
- June 22, 2020
- Change Notification Approval Date
- March 16, 2023
- Retention Due Date
- June 21, 2025
Product description
Centricity PACS software product is intended for the storage, reading, diagnostic review, analysis, annotation, distribution, printing, editing, and processing of digital images and data acquired from diagnostic imaging devices. The Centricity PACS Workstation software is intended for use as a primary diagnostic and analysis tool for diagnostic images by trained healthcare professionals, including radiologists, physicians, technologists, clinicians and nurses. It is also intended for use as a clinical review workstation throughout the healthcare facility.
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)
- Centricity PACS
- Model Identifier(s)
- 840682145558
About this record
Access comprehensive regulatory information for GE Centricity PACS in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0504619 and owned by GE Healthcare. The device was registered on June 22, 2020.
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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