Clearance Summary
Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX) received FDA 510(k) clearance under submission number K252103, sponsored by Mighty Oak Medical. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2025-12-02.
- Submission: K252103
- Applicant / Sponsor: Mighty Oak Medical
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.2050
- Decision date: 2025-12-02
Classification & Regulation
This clearance is catalogued under FDA product code QIH and 21 CFR 892.2050, within the Radiology review panel as a Class II device.