K260322
- 510(k) number
- K260322
- Device name
- Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX)
- Applicant
- Mighty Oak Medical CO · US
- Product code
- QIH — Automated Radiological Image Processing Software
- Decision date
- 2026-06-11
- Date received
- 2026-01-30
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K260322.pdf
Official FDA record: K260322
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.