Picture Archiving and Communication System - India CDSCO Medical Device Registration

Picture Archiving and Communication System is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2023/001208_89ecc99c789dd4f064aec07242b1cc7e_86101866d3a30d8376829f186cee2a4a. This device is marketed under the brand name Fusion Bx 2.0. The license holder is NovoMed Incorporation Pvt. Ltd., and it is classified as Device Class Class B. The approving authority is CDSCO.

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CDSCO Registered

Class Class B

Picture Archiving and Communication System

UID: IMP/MD/2023/001208_89ecc99c789dd4f064aec07242b1cc7e_86101866d3a30d8376829f186cee2a4a

Brand Name

Fusion Bx 2.0

License Holder

NovoMed Incorporation Pvt. Ltd.

Device Class

Class B

Approving Authority

CDSCO

Product Information

Fusion Bx is intended for use by physicians for enhanced visualization of ultrasound imaging of the prostate in clinic and hospital settings. It provides 2D and 3D image visualization including review, manipulation, and analysis tools. Additional features include patient data management, image measurement, multiplanar reconstruction, 3D image registration, segmentation, image annotation, and to record the locations where the biopsies were acquired during the procedure.