510(k) K251532
- Device
- Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX)
- Applicant
- Mighty Oak Medical
- 510(k) number
- K251532
- Product code
- LLZ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-11-03
- Date received
- 2025-05-19
- Regulation
- 892.2050
- Classification name
- System, Image Processing, Radiological
- Medical specialty
- Radiology
- Review panel
- Radiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
- Source
- FDA openFDA 510(k) dataset plus migrated FDA.report data
Related Records
Applicant Contact
- Contact
- Mark Wylie
- Address
- 750 W. Hampden Ave. Suite 120 Englewood CO US 80110 80110
FDA Registration Numbers
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Source Documents
FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON
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