K241696
- 510(k) number
- K241696
- Device name
- Ortho AI
- Applicant
- Ortho Ai, LLC NY · US
- Product code
- QIH — Automated Radiological Image Processing Software
- Decision date
- 2025-01-02
- Date received
- 2024-06-12
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
510(k) Summary (official FDA PDF): K241696.pdf
Official FDA record: K241696
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.