510(k) · Cleared
ClearedAcorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mighty Oak Medical · QIH Automated Radiological Image Processing Software
Cleared on Jun 11, 2026 as substantially equivalent to K252103 (Mighty Oak Medical, 2025) after a 132-day review. Its family tree reaches back 16 generations to 1991.
- Decided
- Jun 11, 2026
- Review
- 132 days
- Class
- Class II
- Product code
- QIH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 16 generations to K904519 (1991). 46 ancestors in all, the oldest K896095 (1990). No later device cites it as a predicate yet.
- Root · 16 generations backK904519 Agfa Diagnostic Center (Adc)Enhanced Imaging Technologies, Inc. · 1991
- 12 generations between
- 3 generations backK231917 VEA AlignEos Imaging · 2024
- 2 generations backK240582 VEA Align; spineEOSEos Imaging · 2024
- 1 generation backK252103 Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX)Mighty Oak Medical · 2025
- This deviceK260322 Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX)Mighty Oak Medical · 2026
Show all 16 generations
- Root · 16 generations backK904519 Agfa Diagnostic Center (Adc)Enhanced Imaging Technologies, Inc. · 1991
- 15 generations backK974597 Adc Compact (Agfa Diagnostic Center)Bayer Corp., Agfa Div. · 1998 · Recalled
- 14 generations backK013138 Adc Compact PlusAgfa-Gevaert AG · 2001
- 13 generations backK022881 Cedara I-SoftviewCedara Software Corp. · 2002 · Recalled
- 12 generations backK071972 Orthopedic Software for Impax WorkstationsAgfa Healthcare Corp. · 2007
- 11 generations backK080529 Stereos WorkstationBiospace Med · 2008
- 10 generations backK090050 Stereos WorkstationBiospace Med · 2010
- 9 generations backK101398 Stereos WorkstationBiospace Med · 2011 · Recalled
- 8 generations backK113344 Stereos WorkstationEos Imaging · 2012
- 7 generations backK130395 Stereos WorkstationEos Imaging, Inc. · 2013 · Recalled
- 6 generations backK141137 Stereos WorkstationEos Imaging · 2014
- 5 generations backK160914 sterEOS WorkstationEos Imaging, Inc. · 2016
- 4 generations backK172346 sterEOS WorkstationEos Imaging · 2018 · Recalled
- 3 generations backK231917 VEA AlignEos Imaging · 2024
- 2 generations backK240582 VEA Align; spineEOSEos Imaging · 2024
- 1 generation backK252103 Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX)Mighty Oak Medical · 2025
- This deviceK260322 Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX)Mighty Oak Medical · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −16 | K904519 | Agfa Diagnostic Center (Adc) | Enhanced Imaging Technologies, Inc. | 1991 | — |
| −15 | K974597 | Adc Compact (Agfa Diagnostic Center) | Bayer Corp., Agfa Div. | 1998 | 1 |
| −14 | K013138 | Adc Compact Plus | Agfa-Gevaert AG | 2001 | — |
| −13 | K022881 | Cedara I-Softview | Cedara Software Corp. | 2002 | 3 |
| −12 | K071972 | Orthopedic Software for Impax Workstations | Agfa Healthcare Corp. | 2007 | — |
| −11 | K080529 | Stereos Workstation | Biospace Med | 2008 | — |
| −10 | K090050 | Stereos Workstation | Biospace Med | 2010 | — |
| −9 | K101398 | Stereos Workstation | Biospace Med | 2011 | 1 |
| −8 | K113344 | Stereos Workstation | Eos Imaging | 2012 | — |
| −7 | K130395 | Stereos Workstation | Eos Imaging, Inc. | 2013 | 1 |
| −6 | K141137 | Stereos Workstation | Eos Imaging | 2014 | — |
| −5 | K160914 | sterEOS Workstation | Eos Imaging, Inc. | 2016 | — |
| −4 | K172346 | sterEOS Workstation | Eos Imaging | 2018 | 1 |
| −3 | K231917 | VEA Align | Eos Imaging | 2024 | — |
| −2 | K240582 | VEA Align; spineEOS | Eos Imaging | 2024 | — |
| −1 | K252103 | Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX) | Mighty Oak Medical | 2025 | — |
| 0 (this device) | K260322 | Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX) | Mighty Oak Medical | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1993 | 2 | 0 |
| 1994 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 4 | 0 |
| 2002 | 2 | 0 |
| 2003 | 2 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2008 | 2 | 0 |
| 2011 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in QIH? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new QIH device
- #1 K213998 cvi42 Auto Imaging Software Applicationscore 23.5 · 7 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K252103 | Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX)Summary page 5…Acorn 3D Software & 3DP Model 510(k) Product Code Trade Name Manufacturer Predicate Device K252103 QIH, LLZ Acorn 3D Software & 3DP Model Mighty Oak Medical Reference Devices K251532… | 2025 |
| † | K251532 | Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX) | 2025 |
| † | K141669 | Surgimap | 2014 |
| † | K213975 | KEOPS Balance Analyzer 3D | 2022 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 35 years and passes through 9 companies; a new generation was cleared every 1.5 years on median.
- 9 of the 46 ancestors have a recall of any class.
How does its category compare?
All QIH devicesQIH Automated Radiological Image Processing Software: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · QIH
94in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QIH
150in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · QIH
1so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · QIH
4in 2025
MAUDE reports naming product code QIH, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 2 | — | 0 | 0 |
| 2020 | 11 | 145 | 0 | 0 |
| 2021 | 19 | 125 | 0 | 0 |
| 2022 | 25 | 134 | 0 | 0 |
| 2023 | 45 | 151 | 0 | 0 |
| 2024 | 64 | 141 | 0 | 2 |
| 2025 | 94 | 150 | 0 | 4 |
| 2026 | 78 | 130 | 1 | — |
What is it indicated for?
Acorn 3D Software is a modular image processing software intended for use as an interface for visualization of medical images, segmentation, anatomical measurements, treatment planning, treatment simulation, and production of an output file. The Acorn 3D Segmentation module is intended for use as a software interface and image segmentation system for the transfer of CT, sCT, or CTA medical images to an output file. Acorn 3D Segmentation is also intended…
Read the full statement (230 words)
Acorn 3D Software is a modular image processing software intended for use as an interface for visualization of medical images, segmentation, anatomical measurements, treatment planning, treatment simulation, and production of an output file.
The Acorn 3D Segmentation module is intended for use as a software interface and image segmentation system for the transfer of CT, sCT, or CTA medical images to an output file. Acorn 3D Segmentation is also intended for measuring and treatment planning. The Acorn 3D Segmentation output can also be used for the fabrication of physical replicas of the output file using additive manufacturing methods, Acorn 3DP Models. The physical replica can be used for diagnostic purposes in the field of musculoskeletal and craniomaxillofacial applications.
The Acorn 3D Alignment and Measurement module contains registration capabilities and measurement functionality based on anatomical reference geometry. It is intended to allow the user to align anatomical structures between datasets, perform spinopelvic measurements on 3D models of anatomy, and plan surgical procedures in pediatric and adult patients.
The Acorn 3D Trajectory Automation module may be used to plan pedicle screw placement in the thoracic and lumbar regions of the spine in pediatric and adult patients.
The Acorn 3D Correction module may be used to plan and simulate aspects of surgical procedures in pediatric and adult patients.
Acorn 3D Software and 3DP Models should be used in conjunction with expert clinical judQment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K260322 · printed Nov 6, 2026
Cite this page
510(k) Report. “K260322: Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K260322
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026