K254207
- 510(k) number
- K254207
- Device name
- AiORTA - Plan v2.0
- Applicant
- ViTAA Medical Solutions, Inc. CA
- Product code
- QIH — Automated Radiological Image Processing Software
- Decision date
- 2026-03-30
- Date received
- 2025-12-29
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K254207.pdf
Official FDA record: K254207
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.