Software - India CDSCO Medical Device Registration

Software is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2023/000701_719d067b229178f03bcfa1da4ac4dede_04acadee4c71f4a2ec8241d47dfa4b13. This device is marketed under the brand name SyMRI 11. The license holder is Bioquest Healthcare 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

Software

UID: IMP/MD/2023/000701_719d067b229178f03bcfa1da4ac4dede_04acadee4c71f4a2ec8241d47dfa4b13

Brand Name

SyMRI 11

License Holder

Bioquest Healthcare Pvt Ltd

Device Class

Class B

Approving Authority

CDSCO

Product Information

SyMRI is a post-processing software medical device intended for use in visualization of soft tissue. SyMRI analyzes input data from MR imaging systems. SyMRI utilizes data from a multi-delay, multi-echo acquisition(SyMRI 11) to generate parametric maps of R1, R2 relaxation rates, and proton density (SyMRI 11). SyMRI can generate multiple image contrasts from the parametric maps. SyMRI enables post-acquisition image contrast adjustment. SyMRI is indicated for head, neck, spine, and knee imaging. SyMRI is also intended for automatic labeling, visualization and volumetric quantification of segmentable brain tissues from a set of MR images. Brain tissue volumes are determined based on modeling of parametric maps from MDME. When interpreted by a trained physician, SyMRI images can provide information useful in determining diagnosis. SyMRI should always be used in combination with at least one other, conventional MR acquisition (SyMRI 11).

Class B

Software

Brand: TactiCath Ablation Catheter Sensor enabled Catheter Catalog Installation

M/s St. Jude Medical India Pvt. Ltd

Class B

Other Products from Bioquest Healthcare Pvt Ltd

Products from the same license holder (1 products)

Software

Brand: SyMRI 11

Class B