# K231955: aprevo® Digital Segmentation

- Pathway: 510(k) (Traditional)
- Applicant: Carlsmed, Inc.
- Decided: Nov 3, 2023 after 123 days
- Product code: QIH (Automated Radiological Image Processing Software)
- 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: 5 generations back to K924630 (1993). 6 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K183105: Mimics Medical, Materialise NV (2019) Summary page 4.

## Most influential descendants
- K253628: Auto-Seg (SO-0012), Spine Auto-Seg (SO-0012) (2026), 0 descendants of its own

## Indications for use
aprevo® Digital Segmentation software is intended to be used by trained, medically knowledgeable design personnel to perform digital image segmentation of the spine, primarily lumbar anatomy. The device inputs DICOM images and outputs a 3-D model of the spine.

Source page: https://510kreport.com/device/K231955
Methodology: https://510kreport.com/methodology