CDSCO UID IMP/MD/2021/000467_1bc4eba47894dc8ff8a1c7c4f3b2f340_073add9897a35afb9759e1826e59cfe5

Imaging System

India Medtronic Private Limited ,Shed No. 3, Block No. 1, Survey No. 389, 400/2A & 2C, Pudur Main Road, Kuthambakkam - 600124, Poonamallee Taluk, Tiruvallur District ,Tiruvallur Tamil Nadu ,600124 ,India·Device Class Class C·India CDSCO·Brand: O-arm O2 Imaging system
Registration details
UID
IMP/MD/2021/000467_1bc4eba47894dc8ff8a1c7c4f3b2f340_073add9897a35afb9759e1826e59cfe5
Device class
Class C
Brand name
O-arm O2 Imaging system
Approving authority
CDSCO
Product information
The O-arm O2 Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D imaging and is intended to be used where a physician benefits from 2D and 3D information of anatomic structures and objects with high x-ray attenuation such as bony anatomy and metallic objects. The O-arm O2 Imaging System is compatible with certain Image Guided Surgery Systems.
Similar products (3)
Other products with the same name or brand
Imaging System
Brand: OPTIS Mobile System, OPTIS Mobile System Installation Kit, OPTIS Mobile System Upgrade Kit, OPTIS Mobile System
M/s St. Jude Medical India Pvt. Ltd
Class B
Imaging System
Brand: OPTIS Mobile System, OPTIS Mobile System Installation Kit, OPTIS Mobile System Upgrade Kit, OPTIS Mobile System
M/s St. Jude Medical India Pvt. Ltd
Class B
Imaging System
Brand: OPTIS Mobile System, OPTIS Mobile System Installation Kit, OPTIS Mobile System Upgrade Kit, OPTIS Mobile System
M/s St. Jude Medical India Pvt. Ltd
Class B
Other products from India Medtronic Private Limited ,Shed No. 3, Block No. 1, Survey No. 389, 400/2A & 2C, Pudur Main Road, Kuthambakkam - 600124, Poonamallee Taluk, Tiruvallur District ,Tiruvallur Tamil Nadu ,600124 ,India
Products from the same license holder (10 products)
Orthosis, spinal pedicle fixation, for degenerative disc disease
Brand: CD HORIZON® Spinal System
Class C
Orthosis, spinal pedicle fixation, for degenerative disc disease
Brand: CD HORIZON® Spinal System
Class C
Biopsy Needle Kit, Passive
Brand: Biopsy Needle Kit
Class B
IV Cannulae
Brand: Sterile Cannula
Class B
Absorbable Antibacterial Envelope
Brand: Tyrx
Class D
Pacemaker
Brand: Vitatron
Class D
Pacemaker
Brand: Vitatron
Class D
Balloon Catheter
Brand: Chameleon PTA Balloon Catheter with Injection Port
Class B
Strata
Brand: Strata NSC Valve
Class C
L/P Shunts
Brand: CSF-Lumboperitoneal Catheter System
Class D
About this record

Imaging System is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2021/000467_1bc4eba47894dc8ff8a1c7c4f3b2f340_073add9897a35afb9759e1826e59cfe5. This device is marketed under the brand name O-arm O2 Imaging system. The license holder is India Medtronic Private Limited ,Shed No. 3, Block No. 1, Survey No. 389, 400/2A & 2C, Pudur Main Road, Kuthambakkam - 600124, Poonamallee Taluk, Tiruvallur District ,Tiruvallur Tamil Nadu ,600124 ,India, and it is classified as Device Class Class C. The approving authority is CDSCO.

This page provides comprehensive regulatory information including complete registration details, license holder information, device classification, and related products. Pure Global AI offers free access to 71,807+ India medical device registrations, helping global MedTech companies identify partners, analyze markets, and discover business opportunities efficiently.