# K243069: Lumys (V1)

- Pathway: 510(k) (Traditional)
- Applicant: Intradys
- Decided: May 2, 2025 after 217 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: 15 generations back to K913770 (1991). 169 ancestors in all.
No later device cites it as a predicate yet.
0 of 170 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K221796: Cyware 4H and Cysart 4H, Abys Medical (2022) Summary page 5.

## Indications for use
LUMYS is intended for use as a software interface and image segmentation system, which is used to carry out pre-surgical planning tasks. LUMYS is intended to be used by clinicians with appropriate clinical judgement. LUMYS is a medical display software intended for 3D image visualization and image interaction. The stereoscopic 3D images are generated from 3D volumetric data acquired from a CT scan source. The device is intended to provide visual information to be used by clinicians with appropriate clinical judgement for analysis of surgical options, and the intraoperative display of the images. The primary surgeon wears a Microsoft Hololens™ Head Mounted Display (HMD) and consults with external users who can perform pre-surgical tasks such as annotating 3D images, uploading files and speaking with the surgeon. The surgeon must cease communication once surgery begins. LUMYS is intended to be used as an adjunct to the interpretation of images performed using diagnostic imaging systems and is not intended for primary diagnosis. LUMYS is intended to be used as a reference display consultation software, which assists the clinician with appropriate clinical judgement who is responsible for making all final patient management decisions.

Source page: https://510kreport.com/device/K243069
Methodology: https://510kreport.com/methodology