Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

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

K-Number: K251532 · 2025-11-03

ApplicantMighty Oak Medical
Decision Date2025-11-03
Product CodeLLZ
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 2025-11-03 under approval number K251532. The device is classified under product code LLZ. 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 2025-11-03. It is manufactured by Mighty Oak Medical. The 510(k) number is K251532.

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 2025-11-03, under approval number K251532.

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 LLZ.

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

K234009Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX) K252103Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX) K253472FIREFLY® Pedicle Screw Navigation Guide

Related Devices (Code: LLZ)

K161959ClearView cCADClearview Diagnostics, Inc. K163539Ez3D-i / E3Ewoosoft Co., Ltd. K162955Multi-Modality Tumor Tracking (MMTT) applicationPhilips Medical Systems Nederland B.V. K160852ZiaZetta Medical Technologies, LLC K162376CAAS MR 4D FlowPie Medical Imaging BV K161322CT CoPilotZepmed, LLC

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.

↑