# K222458: Aibolit 3D+

- Pathway: 510(k) (Traditional)
- Applicant: Aibolit Technologies, LLC
- Decided: Jan 12, 2023 after 150 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)
- K211443: Aibolit 3D+, Aibolit Technologies, LLC (2022) Summary page 4.
- K173274: Ceevra Reveal 2.0, Ceevra, Inc. (2018) Summary page 4.

## Indications for use
Aibolit 3D+ 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 and MRI imaging devices. Aibolit 3D+ is intended as software for preoperative surgical planning, training, patient information and as software for the intraoperative display of the multidimensional digital images. Aibolit 3D+ is designed for use by health care professionals and is intended to assist the clinician who 1s responsible for making all final patient management decisions.

Source page: https://510kreport.com/device/K222458
Methodology: https://510kreport.com/methodology