Diagnostic X-ray system - India CDSCO Medical Device Registration

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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CDSCO Registered

Class Class C

Diagnostic X-ray system

UID: IMP/MD/2021/000332_d5321e881850e10b5abf6265ffcde14b_8ac7b00c84ec682aad7c33232ed89e5c

Brand Name

Optima XR 646

License Holder

Wipro GE Healthcare Private Limited

Device Class

Class C

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

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Radiographic system

Brand: Optima XR 646

Wipro GE Healthcare Private Limited

Diagnostic X-ray system - India CDSCO Medical Device Registration

Brand Name

License Holder

Device Class

Approving Authority

Product Information

DJ Fang

Radiographic system

X-RAY

X- Ray

Interventional Radiology - X-ray system/Medical X-ray angiography equipment

SPECT/CT

X-ray system

X-ray system

Mobile diagnostic X-ray and Fluoroscopic system

Digital Mobile X-ray system with Fluoroscopic

Surgery

Neonatal Phototherapy Unit

Electrocardiograph

Electrocardiograph

Ultrasound Equipment

Ultrasound Equipment

Ultrasound Equipment

X-RAY

PET/CT

Computed Tomography

Magnetic Resonance Imaging