# K253628: Auto-Seg (SO-0012), Spine Auto-Seg (SO-0012)

- Pathway: 510(k) (Traditional)
- Applicant: Agada Medical, Ltd.
- Decided: Jun 29, 2026 after 222 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: 6 generations back to K924630 (1993). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K231955: aprevo® Digital Segmentation, Carlsmed, Inc. (2023) Summary page 6.

## Indications for use
The AGADA SPINE Auto-Seg device is image processing software intended to provide qualitative information from analysis of previously acquired Computed Tomography (CT) DICOM images. The outputs of the software analysis are to be used to support spine surgeons in assessment of musculoskeletal diseases and surgical planning for adults 18 years of age and older. Product functions include; segmentation of thoracic and lumbar vertebrae and pelvis, and labelling of vertebra and pelvis objects. The Auto-Seg device does not provide diagnosis nor recommend treatment and is to be used only as supporting information in clinical decision making. The device is not intended for use with patients with spinal or pelvic implants.

Source page: https://510kreport.com/device/K253628
Methodology: https://510kreport.com/methodology