GE Max Field of View 2 (MaxFOV 2) reconstruction software - HSA Registration DE0506641
Access comprehensive regulatory information for GE Max Field of View 2 (MaxFOV 2) reconstruction 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 DE0506641 and owned by GE HangWei Medical Systems Co. Ltd. The device was registered on February 11, 2022.
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.
The MaxFOV 2 reconstruction software is intended for head and whole body CT scans. The deep learning based Max Field of View (MaxFOV 2) is a CT image reconstruction method intended to produce images of the head and whole-body using Axial, Helical, and Cine acquisitions. MaxFOV 2 is designed to extend the nominal display field of view (DFOV) for cases where patient size and positioning requirements result in a portion of the patient's body to be outside of the nominal DFOV. These extended FOV images are intended for use in radiation therapy planning and are clinically useful for the simulation and planning of radiation therapy for the treatment of cancer for patients. They can also be used for visualization of patient anatomy for cases not involving therapy planning. MaxFOV 2 is intended for patients of all ages, especially bariatric patients.