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Agfa IMPAX Picture Archiving and Communication System (PACS) - HSA Registration DE0014731

Access comprehensive regulatory information for Agfa IMPAX Picture Archiving and Communication System (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 DE0014731 and owned by Agfa Healthcare N.V.. The device was registered on February 07, 2014.

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
DE0014731
Agfa IMPAX Picture Archiving and Communication System (PACS)
HSA Registration Number: DE0014731
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Product Description

IMPAX is a software only PACS device, which comprised of traditional PACS components including a server and various Client Application Display stations. The software in the Application display Workstations within IMPAX allows users to display, manipulate and markup diagnostic images from various modalities.

Device Classification
Device Class
CLASS B
Medical Speciality Area
Radiology / Imaging
HSA Product Code
Refer to CRPNS
HS Code
90181900
Registration Information
Registration Number
DE0014731
Registration Date
February 07, 2014
Retention Due Date
February 06, 2026
Product Owner
Short Name
Agfa Healthcare N.V.
Address
Septestraat 27,, 2640 Mortsel, BELGIUM
Registrant
Address
62 UBI ROAD 1, OXLEY BIZHUB 2, #08-22, SINGAPORE 408734
Importer
Address
62 UBI ROAD 1, OXLEY BIZHUB 2, #08-22, SINGAPORE 408734
Model Information
Model Name(s)
IMPAX 6.5 IMPAX PET-CT Viewing IMPAX Virtual Colonoscopy IMPAX Volume Viewing
Model Identifier(s)
6.5 IMPAX PET-CT Viewing 2.2 IMPAX Virtual Colonoscopy 2.2 IMPAX Volume Viewing 2.2