# K213215: VSI HoloMedicine

- Pathway: 510(k) (Traditional)
- Applicant: Apoqlar GmbH
- Decided: Nov 25, 2022 after 422 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.
2 later devices descend from it; 2 cite it directly.
0 of 57 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 5.

## Most influential descendants
- K251577: Laia XR (2026), 0 descendants of its own
- K240094: LumiNE US; Lumi (2024), 0 descendants of its own

## Indications for use
VSI HoloMedicine® is a software device for displaying digital medical images acquired from CT, Angio CT, MRI, CBCT, PET, and SPECT sources. It is intended to visualize 3D imaging holograms of the patient for pre-operative planning outside and/or inside the surgical room. When accessing VSI HoloMedicine® from a wireless head-mounted display (HMD) or PC monitor, images viewed are for informational purposes only and not intended for diagnostic use. VSI HoloMedicine® is indicated for use by qualified healthcare professionals including surgeons, radiologists, physicians, and technologists.

Source page: https://510kreport.com/device/K213215
Methodology: https://510kreport.com/methodology