Singapore HSA registration DE0509300
FUJIFILM SYNAPSE PACS Software
Device classification
- Device Class
- CLASS B
- Medical Speciality Area
- General Hospital
Registration information
- Registration Number
- DE0509300
- Registration Date
- May 20, 2024
- Retention Due Date
- May 19, 2025
Product description
FUJIFILM Synapse PACS Software is intended for use as a web-based application on an off-the shelf PC which meets or exceeds minimum specifications and is networked with a FUJIFILM Synapse PACS server. The FUJIFILM Synapse PACS Software can process medical images from DICOM compliant modalities and non-DICOM sources. The FUJIFILM Synapse PACS Software provides toolsets for performing measurements on DICOM images, importing and presenting data from modalities (DICOM and non-DICOM), solving clinical calculations, and creating and distributing structured reports. The FUJIFILM Synapse PACS Software is intended to serve as the primary user interface for the processing of medical images for presentation on displays appropriate to the medical task being performed. It enables the display, comparison, and fusion of 3D (MIP/MPR) of CT, MR, PET, and SPECT studies.
Product Owner
- Short Name
- FUJIFILM Healthcare Americas Corporation
- Address
- 81 Hartwell ave, Suite 300, Lexington, MA 02421, UNITED STATES
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
- Model Identifier(s)
- SYNAPSE PACS
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 DE0509300 and owned by FUJIFILM Healthcare Americas Corporation. The device was registered on May 20, 2024.
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.
Free DatabasePowered by Pure Global AIHSA Official DataCLASS B