K252103

Substantially Equivalent

Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX)

Applicant: Mighty Oak Medical
Product code: QIH
Advisory panel: Radiology
Date received: 2025-07-03
Decision date: 2025-12-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Englewood, CO, US

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