Singapore HSA registration DE0012581
Fujifilm Synapse PACS Software
Singapore·CLASS B·FUJIFILM CORPORATION·Registered March 15, 2013Device 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 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.
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
About this record
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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