Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX)
FDA 510(k) K252103 · Mighty Oak Medical
510(k) numberK252103
Submission
- Device name
- Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX)
- Applicant
- Mighty Oak Medical
Englewood, CO, US - Received
- July 3, 2025
- Decision date
- December 2, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- QIH – Automated Radiological Image Processing Software
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 892.2050
- Specialty
- Radiology
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 510(k)s with product code QIH
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261795 | Quicktome Software SuiteQIH · Traditional | Omniscient Neurotechnology Pty, Ltd. | 09/10/2026SE |
| K260879 | 4DMQIH · Traditional | Invia, LLC | 09/10/2026SE |
| K251417 | ReVISION 2QIH · Traditional | Argus Cognitive, Inc. | 09/09/2026SE |
| K260525 | NextMR SpineQIH · Traditional | MRI2CT, Inc. | 09/04/2026SE |
| K260811 | Heartvue.ProtonQIH · Traditional | Heartvue.ai, Inc. | 08/26/2026SE |
| K261595 | Ceevra Reveal 4QIH · Traditional | Ceevra, Inc. | 08/25/2026SE |
| K262127 | DS Core CBCT AnatomyQIH · Traditional | Dentsply Sirona | 08/21/2026SE |
| K260584 | BoneMRIQIH · Traditional | Mriguidance B.V. | 08/21/2026SE |
| K261641 | Lower Limb AI (LLAI)QIH · Traditional | AI Planning Logic, Inc. | 08/18/2026SE |
| K253794 | Prostate CoreQIH · Traditional | Lucida Medical, Ltd. | 08/10/2026SE |
More from Lucida Medical, Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K260322 | Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX)QIH · Traditional | 06/11/2026SE |
| K253472 | FIREFLY® Pedicle Screw Navigation GuidePQC · Traditional | 02/25/2026SE |
| K251532 | Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX)LLZ · Traditional | 11/03/2025SE |
| K234009 | Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX)QIH · Traditional | 07/12/2024SE |
| K220132 | FIREFLY® Cervical Navigation GuideQSD · Traditional | 10/26/2022SE |
| K181883 | FIREFLY® Midline Navigation GuidePQC · Traditional | 10/03/2018SE |
| K181399 | FIREFLY® Pedicle Screw Navigation GuidePQC · Traditional | 07/24/2018SE |
| K162419 | FIREFLY® Pedicle Screw Navigation GuidePQC · Traditional | 10/28/2016SE |
| K143222 | FIREFLY Pedicle Screw Navigation GuideMNI · Traditional | 12/11/2015SE |
Questions and answers
When was Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX) cleared by the FDA?
Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX) (K252103) received a 510(k) decision of Substantially Equivalent on December 2, 2025, 152 days after the submission was received.
What is the product code of K252103?
The FDA product code is QIH – Automated Radiological Image Processing Software, a Class II (moderate risk) device regulated under 21 CFR 892.2050.