Identity
- Trade Name
- Ikshana FDA UDI
- Generic Name
- Radiology DICOM image processing application software FDA UDI
- 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. FDA UDI
- Model / Reference
- V1.0 FDA UDI
- Description
- 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. FDA UDI
Identifiers
- Primary DI / UDI-DI
- B940IKSHANA0 FDA UDI
- 510(k) Number
- K230249 FDA UDI
- FDA Product Code
- LLZ FDA UDI
- GMDN Term
- Radiology DICOM image processing application software FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.2050 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Radiology DICOM image processing application software
Ikshana by ImmersiveTouch, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- ImmersiveTouch, Inc.
Sources (1)
- FDA UDI 9fd776db-115d-467e-9683-45bdcb1dbb20 34 fields · synced May 31, 2026