# K210072: HOLOSCOPE-i

- Pathway: 510(k) (Traditional)
- Applicant: Real View Imaging, Ltd.
- Decided: May 14, 2021 after 123 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: 1 generation back to K193149 (2019). 1 ancestor in all.
4 later devices descend from it; 2 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K193149: True 3D Viewer Software, Echopixel, Inc. (2019) Summary page 4.

## Most influential descendants
- K223125: XR90 (XR90-Sys) (2023), 1 descendant of its own
- K221796: Cyware 4H and Cysart 4H (2022), 1 descendant of its own
- K253486: SKIA-Head (Model: SKIA-ST00) (2026), 0 descendants of its own
- K243069: Lumys (V1) (2025), 0 descendants of its own

## Indications for use
The HOLOSCOPE-i is a medical display workstation intended for 3D image visualization and image interaction. The holograms are generated from 3D volumetric data acquired from CT and Ultrasound sources. The device is intended to provide visual information to be used by the health care professional for analysis of surgical options, and the intraoperative display of the images. The HOLOSCOPE-i 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. The HOLOSCOPE-i is intended to be used as a reference display for consultation to assist the clinician who is responsible for making all final patient management decisions.

Source page: https://510kreport.com/device/K210072
Methodology: https://510kreport.com/methodology