# K230044: Pre-Sure

- Pathway: 510(k) (Traditional)
- Applicant: Lazarus 3D
- Decided: May 26, 2023 after 140 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: 7 generations back to K924630 (1993). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K201835: Pre-Sure, Lazarus 3D, Inc. (2021) Summary page 5.

## Indications for use
The Pre-Sure software system is intended for use as a software interface and image segmentation system for the transfer of DICOM imaging information from a medical scanner to an output file. It is also intended as pre-operative software for surgical planning. For this purpose, the output file may be used to produce a physical replica. The physical replica is intended for adjunctive use along with other diagnostic tools and expert clinical judgment for diagnosis, patient management, and/or treatment selection of genitourinary, cardiovascular, neurological, respiratory, musculoskeletal, gastrointestinal, craniofacial, and pediatric applications.

Source page: https://510kreport.com/device/K230044
Methodology: https://510kreport.com/methodology