# K230249: Ikshana

- Pathway: 510(k) (Traditional)
- Applicant: Immersivetouch
- Decided: Oct 16, 2023 after 259 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 13 generations back to K913770 (1991). 54 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 56 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K190764: SurgicalAR, Medivis, Inc. (2019) Summary page 4.

## Most influential descendants
- K253486: SKIA-Head (Model: SKIA-ST00) (2026), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K230249
Methodology: https://510kreport.com/methodology