510(k) K234009

Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX) by Mighty Oak Medical — Product Code QIH

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: July 12, 2024
Date Received: December 19, 2023
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Automated Radiological Image Processing Software
Device Class: Class II
Regulation Number: 892.2050
Review Panel: RA
Submission Type

To provide automated radiological image processing and analysis tools. Software implementing artificial intelligence including nonadaptive machine learning algorithms trained with clinical and/or artificial data. In these devices, the algorithm training data typically impacts device performance. Adaptive AI algorithms are not within scope of this product code.

Other clearances by Mighty Oak Medical

K253472 — FIREFLY® Pedicle Screw Navigation Guide (February 25, 2026)
K252103 — Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX) (December 2, 2025)
K251532 — Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX) (November 3, 2025)
K220132 — FIREFLY® Cervical Navigation Guide (October 26, 2022)
K181883 — FIREFLY® Midline Navigation Guide (October 3, 2018)
K181399 — FIREFLY® Pedicle Screw Navigation Guide (July 24, 2018)
K162419 — FIREFLY® Pedicle Screw Navigation Guide (October 28, 2016)
K143222 — FIREFLY Pedicle Screw Navigation Guide (December 11, 2015)

Other clearances for product code QIH

K252261 — InferCare RECIST (March 13, 2026)
K252538 — CEPHX3D (March 5, 2026)
K253593 — Clarius Ejection Fraction AI (March 2, 2026)
K253535 — Ligence Heart (February 27, 2026)
K260217 — AI Platform 2.2 (AIP002) (February 24, 2026)
K252084 — AI4CMR v2.0 (February 11, 2026)
K254016 — MI View&GO (February 10, 2026)
K252091 — Surgical Reality Viewer (January 29, 2026)
K252496 — Neurophet AQUA AD Plus (January 29, 2026)
K253735 — AV Vascular (January 22, 2026)