GE Definium Tempo Digital Radiographic Systems - HSA Registration DE0506714
Access comprehensive regulatory information for GE Definium Tempo Digital Radiographic Systems in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0506714 and owned by GE Hualun Medical Systems Co Ltd. The device was registered on March 10, 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 Definium Tempo Pro/ Definium Tempo is intended to generate digital radiographic images of the skull, spinal column, chest, abdomen, extremities, and other body parts in patients of all ages. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position and the system is intended for use in all routine radiography exams. Optional image pasting function enables the operator to stitch sequentially acquired radiographs into a single image. Optional Dual Energy function enables users to acquire a low-kVp image and a high kVp image to create a soft tissue and bone image. This device is not intended for mammographic applications.