510(k) · Cleared
ClearedVEA Align
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Eos Imaging · QIH Automated Radiological Image Processing Software
Cleared on Jan 5, 2024 as substantially equivalent to K172346 (Eos Imaging, 2018) after a 190-day review. Its family tree reaches back 13 generations to 1991. 5 later devices descend from it.
- Decided
- Jan 5, 2024
- Review
- 190 days
- Class
- Class II
- Product code
- QIH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 13 generations to K904519 (1991). 20 ancestors in all. 5 later devices descend from it, 1 citing it directly.
- Root · 13 generations backK904519 Agfa Diagnostic Center (Adc)Enhanced Imaging Technologies, Inc. · 1991
- 9 generations between
- 3 generations backK141137 Stereos WorkstationEos Imaging · 2014
- 2 generations backK160914 sterEOS WorkstationEos Imaging, Inc. · 2016
- 1 generation backK172346 sterEOS WorkstationEos Imaging · 2018 · Recalled
- This deviceK231917 VEA AlignEos Imaging · 2024
- Descendant · cites it directly · 4 of its ownK240582 VEA Align; spineEOSEos Imaging · 2024
- Descendant · 2 generations on · 1 of its ownK252103 Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX)Mighty Oak Medical · 2025
- Descendant · 2 generations on · 1 of its ownK251747 VEA Align; spineEOSEos Imaging · 2025
- Descendant · 3 generations on · 0 of its ownK260322 Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX)Mighty Oak Medical · 2026
- Descendant · 3 generations on · 0 of its ownK251078 AutoDensityEos Imaging · 2025
Show all 13 generations
- Root · 13 generations backK904519 Agfa Diagnostic Center (Adc)Enhanced Imaging Technologies, Inc. · 1991
- 12 generations backK974597 Adc Compact (Agfa Diagnostic Center)Bayer Corp., Agfa Div. · 1998 · Recalled
- 11 generations backK013138 Adc Compact PlusAgfa-Gevaert AG · 2001
- 10 generations backK022881 Cedara I-SoftviewCedara Software Corp. · 2002 · Recalled
- 9 generations backK071972 Orthopedic Software for Impax WorkstationsAgfa Healthcare Corp. · 2007
- 8 generations backK080529 Stereos WorkstationBiospace Med · 2008
- 7 generations backK090050 Stereos WorkstationBiospace Med · 2010
- 6 generations backK101398 Stereos WorkstationBiospace Med · 2011 · Recalled
- 5 generations backK113344 Stereos WorkstationEos Imaging · 2012
- 4 generations backK130395 Stereos WorkstationEos Imaging, Inc. · 2013 · Recalled
- 3 generations backK141137 Stereos WorkstationEos Imaging · 2014
- 2 generations backK160914 sterEOS WorkstationEos Imaging, Inc. · 2016
- 1 generation backK172346 sterEOS WorkstationEos Imaging · 2018 · Recalled
- This deviceK231917 VEA AlignEos Imaging · 2024
Most influential descendants
Showing 5 of 5 · See all- K240582VEA Align; spineEOSEos Imaging · 2024 · cites it directly4descendants
- K252103Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX)Mighty Oak Medical · 2025 · 2 generations on1descendant
- K251747VEA Align; spineEOSEos Imaging · 2025 · 2 generations on1descendant
- K260322Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX)Mighty Oak Medical · 2026 · 3 generations on0descendants
- K251078AutoDensityEos Imaging · 2025 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K904519 | Agfa Diagnostic Center (Adc) | Enhanced Imaging Technologies, Inc. | 1991 | — |
| −12 | K974597 | Adc Compact (Agfa Diagnostic Center) | Bayer Corp., Agfa Div. | 1998 | 1 |
| −11 | K013138 | Adc Compact Plus | Agfa-Gevaert AG | 2001 | — |
| −10 | K022881 | Cedara I-Softview | Cedara Software Corp. | 2002 | 3 |
| −9 | K071972 | Orthopedic Software for Impax Workstations | Agfa Healthcare Corp. | 2007 | — |
| −8 | K080529 | Stereos Workstation | Biospace Med | 2008 | — |
| −7 | K090050 | Stereos Workstation | Biospace Med | 2010 | — |
| −6 | K101398 | Stereos Workstation | Biospace Med | 2011 | 1 |
| −5 | K113344 | Stereos Workstation | Eos Imaging | 2012 | — |
| −4 | K130395 | Stereos Workstation | Eos Imaging, Inc. | 2013 | 1 |
| −3 | K141137 | Stereos Workstation | Eos Imaging | 2014 | — |
| −2 | K160914 | sterEOS Workstation | Eos Imaging, Inc. | 2016 | — |
| −1 | K172346 | sterEOS Workstation | Eos Imaging | 2018 | 1 |
| 0 (this device) | K231917 | VEA Align | Eos Imaging | 2024 | — |
| +1 | K240582 | VEA Align; spineEOS | Eos Imaging | 2024 | — |
| +2 | K252103 | Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX) | Mighty Oak Medical | 2025 | — |
| +2 | K251747 | VEA Align; spineEOS | Eos Imaging | 2025 | — |
| +3 | K260322 | Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX) | Mighty Oak Medical | 2026 | — |
| +3 | K251078 | AutoDensity | Eos Imaging | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 3 | 0 |
| 2002 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 1 | 0 |
| 2025 | 3 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K172346 | sterEOS WorkstationSummary page 4…roduct Code: QIH 3 LEGALLY MARKETED PREDICATE DEVICES 510(k) Product Name Clearance Date K172346 sterEOS Workstation June 2018 4 DEVICE DESCRIPTION VEA Align is a software indi… | 2018 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K240582 | VEA Align; spineEOS | 2024 | 4 |
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 33 years and passes through 8 companies; a new generation was cleared every 1.6 years on median.
- 7 of the 20 ancestors have a recall of any class.
- Of its descendants, K240582 (Eos Imaging, 2024) has gone furthest, with 4 descendants of its own.
- 2 other devices also cite its predicate K172346.
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. 2024, 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?
This cloud-based software is intended for orthopedic applications in both pediatric and adult populations. 2D X-ray images acquired in EOS imaging’s imaging systems is the foundation and resource to display the interactive landmarks overlayed on the frontal and lateral images. These landmarks are available for users to assess patient-specific global alignment. For additional assessment, alignment parameters compared to published normative values may be…
Read the full statement (118 words)
This cloud-based software is intended for orthopedic applications in both pediatric and adult populations.
2D X-ray images acquired in EOS imaging’s imaging systems is the foundation and resource to display the interactive landmarks overlayed on the frontal and lateral images. These landmarks are available for users to assess patient-specific global alignment.
For additional assessment, alignment parameters compared to published normative values may be available.
This product serves as a tool to aid in the analysis of spinal deformities, degenerative diseases, lower limb alignment disorders, and deformities through precise angle and length measurements. It is suitable for use with adult and pediatric patients aged 7 years and older.
Clinical judgment and experience are required to properly use the software.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K231917 · printed Nov 6, 2026
Cite this page
510(k) Report. “K231917: VEA Align.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K231917
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026