X- Ray - India CDSCO Medical Device Registration

X- Ray is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2021/000332_f412c25a3cdeff1e83bb10d8547b4380_f91730f5e6865a68f39a4d40f86727cd. 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

X- Ray

UID: IMP/MD/2021/000332_f412c25a3cdeff1e83bb10d8547b4380_f91730f5e6865a68f39a4d40f86727cd

Brand Name

Optima XR 646

License Holder

Wipro GE Healthcare Private Limited

Device Class

Class C

Approving Authority

CDSCO

Product Information

General Purpose Digital Radiographic Imaging System The Optima XR646 HD 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. The Optima XR646 HD incorporates AutoGrid, which is an optional image processing software installed as a part of the systems Helix image processing software. AutoGrid can be used in lieu of an anti-scatter grid to improve image contrast in general radiographic images by reducing the effects of scatter radiation

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Radiographic system

Brand: Optima XR 646

Wipro GE Healthcare Private Limited

X- Ray - India CDSCO Medical Device Registration

Brand Name

License Holder

Device Class

Approving Authority

Product Information

DJ Fang

Radiographic system

X-RAY

Diagnostic X-ray system

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