Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX)— 510(k) K234009

Name: FDA 510(k) clearance K234009
Creator: U.S. Food and Drug Administration
Published: 2024-07-12

Substantially Equivalent

Mighty Oak Medical

FDA 510(k) clearance K234009 for Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX), Substantially Equivalent on 2024-07-12. Applicant: Mighty Oak Medical. Device class: 2.

Clearance details

Applicant: Mighty Oak Medical
Product code: Code QIH
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2023-12-19
Decision date: 2024-07-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Englewood, CO, US

Download summary PDF View on FDA.gov ↗

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