Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX)— 510(k) K260322
Substantially EquivalentMighty Oak Medical
FDA 510(k) clearance K260322 for Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX), Substantially Equivalent on 2026-06-11. Applicant: Mighty Oak Medical. Device class: 2.
Summary
Mighty Oak Medical's clearance names Acorn 3D Software (AC-SEG-4009) and Acorn 3DP Model (AC-101-XX). The record lists one product code, QIH, automated radiological image processing software, and doesn't say what the 3DP Model is.
Class II, 21 CFR 892.2050. Radiology is both the classification panel and the review panel. It came in as a Traditional 510(k).
Mighty Oak filed from Englewood, Colorado. The decision came 132 calendar days after receipt (January 30 to June 11, 2026).
Clearance details
- Applicant
- Mighty Oak Medical
- Product code
- Product code QIH
- Device class
- Class 2
- Regulation
- 21 CFR 892.2050
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Englewood, CO, US
Recent devices under product code QIH
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