Diagnostic X-ray system
- UID
- IMP/MD/2021/000332_d5321e881850e10b5abf6265ffcde14b_8ac7b00c84ec682aad7c33232ed89e5c
- Device class
- Class C
- Brand name
- Optima XR 646
- License holder
- Wipro GE Healthcare Private Limited
- Approving authority
- CDSCO
- Product information
- 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
Diagnostic X-ray system is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2021/000332_d5321e881850e10b5abf6265ffcde14b_8ac7b00c84ec682aad7c33232ed89e5c. This device is marketed under the brand name Optima XR 646. The license holder is Wipro GE Healthcare Private Limited, and it is classified as Device Class Class C. The approving authority is CDSCO.
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