Pure Global

FUJIFILM SYNAPSE PACS Software - HSA Registration DE0509300

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 Database
Powered by Pure Global AI
HSA Official Data
CLASS B
DE0509300
FUJIFILM SYNAPSE PACS Software
HSA Registration Number: DE0509300
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
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.

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 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