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Fujifilm Synapse PACS Software - HSA Registration DE0012581

Access comprehensive regulatory information for Fujifilm Synapse PACS 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 DE0012581 and owned by FUJIFILM CORPORATION. The device was registered on March 15, 2013.

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
DE0012581
Fujifilm Synapse PACS Software
HSA Registration Number: DE0012581
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Product Description

Intended for processing of medical images for presentation on display from the following modality types: plane X-ray radiography, X-ray computed tomography, magnetic resonance imaging, ultrasound, nuclear medicine and images from other DICOM compliant modalities. Synapse is capable of receiving and displaying mammography images. Synapse does not provide image processing for mammography images.

Device Classification
Device Class
CLASS B
Medical Speciality Area
Radiology / Imaging
HSA Product Code
HSAMDB00112
HS Code
37059010
Registration Information
Registration Number
DE0012581
Registration Date
March 15, 2013
Change Notification Approval Date
November 22, 2022
Retention Due Date
March 14, 2026
Product Owner
Short Name
FUJIFILM
Address
26-30 nishiazabu 2 chome, MINATO-KU TOKYO 106-8620 JAPAN, JAPAN
Registrant
Address
10 NEW INDUSTRIAL ROAD, FUJIFILM BUILDING, SINGAPORE 536201
Importer
Address
10 NEW INDUSTRIAL ROAD, FUJIFILM BUILDING, SINGAPORE 536201
Model Information
Model Name(s)
Synapse Synapse 4.0
Model Identifier(s)
Synapse 3.2.1 Synapse 4.0