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GE 4D View - HSA Registration DE0009487

Access comprehensive regulatory information for GE 4D View in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0009487 and owned by GE Healthcare Austria GmbH & Co OG. The device was registered on August 14, 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
DE0009487
GE 4D View
HSA Registration Number: DE0009487
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Product Description

4D View is intended to be used in medical practices and in clinical departments and serves the purposes of diagnostic interpretation of 3D/4D ultrasound images. 4D View provides the user the ability to display and edit 3D/4D ultrasound images that have been created in certain GE proprietary formats. 4D View is designed to accept, transfer, display, store and process these specific medical data, and enables the user to measure and annotate the images. The medical images, which 4D View displays to the user, can be used for diagnostic purposes. 4D View is intended for professional use only. 4D View is not intended to be used as an automated diagnosis system. 4D View is not intended to operate medical devices in surgery related procedures.

Device Classification
Device Class
CLASS B
Medical Speciality Area
Radiology / Imaging
HSA Product Code
Refer to CRPNS
HS Code
90181900
Registration Information
Registration Number
DE0009487
Registration Date
August 14, 2012
Change Notification Approval Date
October 27, 2015
Retention Due Date
August 13, 2025
Product Owner
Short Name
GE Healthcare Austria
Address
Tiefenbach 15, 4871 Zipf, AUSTRIA
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)
4D-View Standalone Software 4D-View Standalone Software
Model Identifier(s)
H48651SZ H48691KL