K234009
- 510(k) number
- K234009
- 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
- 2024-07-12
- Date received
- 2023-12-19
- 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: K234009.pdf
Official FDA record: K234009
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.