gudid
Primary ID: V1.0
Ikshana (UDI V1.0)
Manufactured by IMMERSIVETOUCH, INC.
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for Ikshana - Primary ID V1.0
Device Regulatory Overview
The Ikshana (Model/Catalog Number: V1.0) is a medical device manufactured by IMMERSIVETOUCH, INC.. This product is indexed under FDA Product Code / Category Classification LLZ within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- V1.0
- Product Code / EMDN
- LLZ
- Device Name
- Ikshana is a software device to display medical images. It includes functions for image review, image manipulation, measurements, and 3D visualization. Medical images may only be interpreted using an FDA-cleared display monitor that meets technical specifications that are reviewed and accepted by the FDA. Ikshana is intended to be used as an adjunct to the interpretation of images performed using diagnostic imaging systems and is not intended for primary diagnosis. Display monitors used for reading medical images for diagnostic purposes must be FDA-approved radiology monitors.Ikshana software is indicated for use by qualified healthcare professionals, including, but not restricted to, radiologists, non-radiology specialists, physicians, and technologists.When accessing the Ikshana software from a wireless stereoscopic head-mounted display (HMD) or mobile device, the images viewed are for informational purposes only and are not intended for diagnostic use.
- Database Sync Date
- 2026-08-09 09:06:20
Full Regulatory Attributes
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{
"review_panel": "AN",
"gudid_di_status": "Published",
"sterilization_methods": ["EO", "Gamma"],
"rx_only": true
}
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Get API Token Access ($49/mo)Frequently Asked Questions
Who is the primary manufacturer of Ikshana?
The registered manufacturer of record for Ikshana is IMMERSIVETOUCH, INC..
What is the Primary UDI-DI identifier for Ikshana?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is V1.0.
What classification code is assigned to this device?
This device is registered under product classification code LLZ.
Similar Classification Devices (LLZ)
Other Devices by IMMERSIVETOUCH, INC.
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