# K253950: Avatar Medical Vision

- Pathway: 510(k) (Traditional)
- Applicant: Avatar Medical
- Decided: Mar 30, 2026 after 110 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: 11 generations back to K924630 (1993). 13 ancestors in all.
No later device cites it as a predicate yet.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K222035: Avatar Medical Software V1, Avatar Medical (2023) Summary page 6.

## Indications for use
Avatar Medical Vision is intended as a medical imaging system that allows the processing, review, analysis, communication and media interchange of multi-dimensional digital images acquired from CT or MR imaging devices. It is also intended as software for preoperative surgical planning, and as software for the intraoperative display of the aforementioned multi-dimensional digital images on a standard (non-stereoscopic) screen in the operating room, and on an autostereoscopic screen or VR headset in a non-sterile room. Avatar Medical Vision is designed for use by healthcare professionals and is intended to assist the clinician who is responsible for making all final patient management decisions.

Source page: https://510kreport.com/device/K253950
Methodology: https://510kreport.com/methodology