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GE Healthcare Centricity* Cardio Imaging 5.0 - HSA Registration DE0011714

Access comprehensive regulatory information for GE Healthcare Centricity* Cardio Imaging 5.0 in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0011714 and owned by GE Healthcare. The device was registered on December 05, 2012.

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
DE0011714
GE Healthcare Centricity* Cardio Imaging 5.0
HSA Registration Number: DE0011714
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Product Description

Centricity* Cardio Imaging is a software only Picture Archiving and Communication System (PACS) medical device. It will be sold as a software only device to operate on general purpose computing hardware. Centricity* Cardio Imaging receives medical images and other information from various data sources. Information can be stored, communicated, processed and displayed within the system or across computer networks at distributed locations. Centricity* Cardio Imaging is intended to assist trained professionals in the viewing, analysis, and diagnostic interpretation of images and other information for the diagnosis and treatment of cardiac and vascular disease. These trained professionals include but are not limited to physicians, cardiologists, radiologists, nurses and technicians. It is not intended for use in the patient vicinity.

Device Classification
Device Class
CLASS B
Medical Speciality Area
Radiology / Imaging
HSA Product Code
Refer to CRPNS
HS Code
90181900
Registration Information
Registration Number
DE0011714
Registration Date
December 05, 2012
Retention Due Date
December 04, 2025
Product Owner
Short Name
GE Healthcare
Address
540 W. Northwest Highway, Barrington IL 60010, 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 1 MARITIME SQUARE, HARBOURFRONT CENTRE, #13-01, SINGAPORE 099253 1 MARITIME SQUARE, HARBOURFRONT CENTRE, #13-01, SINGAPORE 099253
Model Information
Model Name(s)
Centricity* Cardio Imaging Centricity* Cardio Imaging Centricity* Cardio Imaging
Model Identifier(s)
2058544-00x 2062091-00x 2066241-00x