FUJIFILM FUJIFILM Whole Body X-ray CT System FCT iStream - HSA Registration DE0510566
Access comprehensive regulatory information for FUJIFILM FUJIFILM Whole Body X-ray CT System FCT iStream in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0510566 and owned by FUJIFILM Healthcare Corporation. The device was registered on April 08, 2025.
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.
This system is intended to use at any part of the whole body to get computed tomography images and those images are used for diagnostic purposes. The FCT iStream system is indicated to acquire axial volumes of the whole body including the head. Images can be acquired in axial, helical, or dynamic modes. The FCT iStream system can also be used for interventional needle guidance. Volume datasets acquired by an FCT iStream system can be post-processed in the FCT iStream system to provide additional information. Post-processing capabilities of the FCT iStream software include multi-planar reconstruction (MPR), and volume rendering. Volume datasets acquired by an FCT iStream system can be transferred to external devices via a DICOM standard interface.