K253628
- 510(k) number
- K253628
- Device name
- Auto-Seg (SO-0012), Spine Auto-Seg (SO-0012)
- Applicant
- Agada Medical, Ltd. IL
- Product code
- QIH — Automated Radiological Image Processing Software
- Decision date
- 2026-06-29
- Date received
- 2025-11-19
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
510(k) Summary (official FDA PDF): K253628.pdf
Official FDA record: K253628
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.