# K232339: Augmented Reality Application

- Pathway: 510(k) (Traditional)
- Applicant: Sira Medical, Inc.
- Decided: Feb 1, 2024 after 181 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.

## Indications for use
Sira Medical Augmented Reality Application is intended as a medical imaging system that allows the processing, review, analysis, and communication of augmented reality images acquired from the same data used to generate conventional CT scans and MRIs. Sira Medical software is designed for preoperative surgical planning and intended to be used by trained and qualified clinicians who are responsible for making patient management decisions.

Source page: https://510kreport.com/device/K232339
Methodology: https://510kreport.com/methodology