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GE Image Diagnost International MammoWorkstation Software - HSA Registration DE0011795

Access comprehensive regulatory information for GE Image Diagnost International MammoWorkstation Software in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0011795 and owned by GE Healthcare. The device was registered on December 12, 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
DE0011795
GE Image Diagnost International MammoWorkstation Software
HSA Registration Number: DE0011795
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Product Description

MammoWorkstation is designed to assist radiologists in conducting primary diagnostic interpretation for diagnostic and screening mammography through flexible and interactive manipulation of multimodality softcopy images. MammoWorkstation provides image review, manipulation, analysis, post-processing and printing capabilities that support image management display needs in the medical environment. MammoWorkstation is designed to give easy and economic access to and display of multimodality softcopy images, structured reports, and CAD results through interfaces to various image storage devices using DICOM or similar interface standards. MammoWorkstation supports the creation of structured reports according to the DICOM breast imaging report templates. MammoWorkstation supports teleradiology and teleconferencing providing access to multimodality softcopy images and structured reports in multiple locations within and outside the hospital.

Device Classification
Device Class
CLASS B
Medical Speciality Area
Radiology / Imaging
HSA Product Code
Refer to CRPNS
HS Code
90181900
Registration Information
Registration Number
DE0011795
Registration Date
December 12, 2012
Retention Due Date
December 11, 2025
Product Owner
Short Name
GE Healthcare
Address
Image Diagnost International GmbH, Oskar-Schlemmer-strasse 11, 80807 Munchen, GERMANY
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)
Backlight Workflow Reporting IDI Second Edition Keypad CESM MammoDS Premium View
Model Identifier(s)
S30351AC S30351AV S30351AW/EL S30351AY S30351EJ S30351FH S30351FM