# K210344: inVisionOS

- Pathway: 510(k) (Traditional)
- Applicant: Precisionos Technology, Inc.
- Decided: Nov 10, 2021 after 278 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: 9 generations back to K896095 (1990). 33 ancestors in all.
No later device cites it as a predicate yet.
0 of 34 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K201465: SuRgical Planner (SRP) BrainStorm, Surgical Theater, Inc. (2020) Summary page 4.
- K182464: PeekMed, Peek Health, S.A. (2018) Summary page 4.

## Indications for use
inVisionOS is a software-based medical image viewing system intended for use as a software interface for the pre-operative evaluation of surgical treatment options of bone pathologies imaged using CT scans.

Source page: https://510kreport.com/device/K210344
Methodology: https://510kreport.com/methodology