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GE Centricity PACS - HSA Registration DE0504619

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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CLASS B
DE0504619
GE Centricity PACS
HSA Registration Number: DE0504619
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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.

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 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)
Centricity PACS
Model Identifier(s)
840682145558