K253192
- 510(k) number
- K253192
- Device name
- DeepXray Spina
- Applicant
- Alpha Intelligence Manifolds, Inc. TW
- Product code
- SAO — Radiology Software For Opportunistic Evaluation Of L
- Decision date
- 2026-06-10
- Date received
- 2025-09-26
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 2.8 MB · U.S. public domain
Also available from FDA: K253192.pdf
Official FDA record: K253192
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.