# K201835: Pre-Sure

- Pathway: 510(k) (Traditional)
- Applicant: Lazarus 3D, Inc.
- Decided: Jul 8, 2021 after 371 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: 6 generations back to K924630 (1993). 7 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K183489: D2P, 3D Systems, Inc. (2019) Summary page 5.

## Most influential descendants
- K230044: Pre-Sure (2023), 0 descendants of its own

## 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 judgement for diagnosis, patient management, and/or treatment selection of genitourinary applications.

Source page: https://510kreport.com/device/K201835
Methodology: https://510kreport.com/methodology