510(k) · Cleared
ClearedAutoDensity
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 Nov 14, 2025 as substantially equivalent to K251747 (Eos Imaging, 2025) after a 220-day review. Its family tree reaches back 16 generations to 1991.
- Decided
- Nov 14, 2025
- Review
- 220 days
- Class
- Class II
- Product code
- QIH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 16 generations to K904519 (1991). 37 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 backK251747 VEA Align; spineEOSEos Imaging · 2025
- This deviceK251078 AutoDensityEos Imaging · 2025
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 backK251747 VEA Align; spineEOSEos Imaging · 2025
- This deviceK251078 AutoDensityEos Imaging · 2025
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 | K251747 | VEA Align; spineEOS | Eos Imaging | 2025 | — |
| 0 (this device) | K251078 | AutoDensity | Eos Imaging | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1994 | 1 | 0 |
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 4 | 0 |
| 2002 | 2 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2008 | 1 | 0 |
| 2011 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2023 | 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 |
|---|---|---|---|
| * | K251747 | VEA Align; spineEOS Cleared while this submission was under review Summary page 6…duct Code: QIH 3 LEGALLY MARKETED PREDICATE DEVICE 510(k) Product Name Clearance Date K251747 VEA Align August 2025 4 REFERENCE DEVICE 510(k)… | 2025 |
| † | K072847 | Apex 2.0 Software for QDR X-Ray Bone Densitometers | 2008 |
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 34 years and passes through 8 companies; a new generation was cleared every 1.5 years on median.
- 9 of the 37 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. 2025, 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?
AutoDensity is a post-processing software intended to estimate spine Bone Mineral Density (BMD) from EOSedge dual energy images for orthopedic pre-surgical assessment applications. It is an opportunistic tool that enables immediate assessment of bone density from EOSedge images acquired for other purposes.
AutoDensity is not intended to replace DXA screening. Suspected low BMD should be confirmed by a DXA exam.
Clinical judgment and experience are required to properly use the software.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K251078 · printed Nov 6, 2026
Cite this page
510(k) Report. “K251078: AutoDensity.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K251078
Report an extraction error
Are you the manufacturer?
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