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FDA 510(k)

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

K-Number: K234009 · 2024-07-12

ApplicantMighty Oak Medical
Decision Date2024-07-12
Product CodeQIH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX) is a medical device manufactured by Mighty Oak Medical. It received FDA 510(k) clearance on 2024-07-12 under approval number K234009. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX)?

Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX) is a medical device that received FDA 510(k) clearance on 2024-07-12. It is manufactured by Mighty Oak Medical. The 510(k) number is K234009.

When was Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX) approved by the FDA?

Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX) received FDA 510(k) clearance on 2024-07-12, under approval number K234009.

What company makes Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX)?

Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX) is manufactured by Mighty Oak Medical.

What is the FDA product code for Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX)?

The FDA product code for Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX) is QIH.

Related Clinical Trials

NCT07593872 XR-Assisted PET/CT Navigation for Cervical Lymph Node Dissection in Lung Cancer NOT_YET_RECRUITING NCT07179146 A Comparison Of Dental Arch Analysis Using 3d Digital Scanning Versus Conventional Methods In Children COMPLETED NCT07565480 Collection of Training Data for LuminX Probe AI Models NOT_YET_RECRUITING

Related PubMed Literature

PMID: 42174919 Automating Safety Surveillance for Software-Based Medical Devices: Insights from FDA MAUDE Data. Studies in health technology and informatics (2026) PMID: 42082885 Precision Dosing of Vancomycin: A Systematic Review of Population Pharmacokinetics Models and Comparative Evaluation of Software Tools. Clinical pharmacokinetics (2026) PMID: 40408133 A Business Model Framework for Software as a Medical Device Startups in the European Union: Mixed Methods Study. Journal of medical Internet research (2025)

Other Devices by Mighty Oak Medical

K252103Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX) K251532Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX) K253472FIREFLY® Pedicle Screw Navigation Guide

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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