Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX)— 510(k) K260322

Clearance details

Applicant

Mighty Oak Medical

Product code

Code QIH

Device class

Class 2

Regulation

21 CFR 892.2050

Advisory panel

Radiology

Date received

2026-01-30

Decision date

2026-06-11

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Englewood, CO, US

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