510(k) · Cleared
ClearedBunkerhill Abdominal Aortic Quantification (AAQ)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
BunkerHill Health · QIH Automated Radiological Image Processing Software
Cleared on Jul 1, 2025 as substantially equivalent to K230534 (Aidoc Medical, Ltd., 2023) after a 204-day review. Its family tree reaches back 10 generations to 1995.
- Decided
- Jul 1, 2025
- Review
- 204 days
- Class
- Class II
- Product code
- QIH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K945512 (1995). 19 ancestors in all, the oldest K945428 (1995). No later device cites it as a predicate yet.
- Root · 10 generations backK945512 HRSW Option for CT Twin FlashElscint, Inc. · 1995
- 6 generations between
- 3 generations backK203256 Imbio RV/LV SoftwareImbio, LLC · 2021
- 2 generations backK221100 Viz RV/LVViz. Ai, Inc. · 2022
- 1 generation backK230534 BriefCase-QuantificationAidoc Medical, Ltd. · 2023
- This deviceK243779 Bunkerhill Abdominal Aortic Quantification (AAQ)BunkerHill Health · 2025
Show all 10 generations
- Root · 10 generations backK945512 HRSW Option for CT Twin FlashElscint, Inc. · 1995
- 9 generations backK970980 Cardiac Scoring for CT ScannersElscint, Inc. · 1997
- 8 generations backK982004 CT Coronary Artery Calcification Scoring (Cacs) Option for Advantage…General Electric Co. · 1998
- 7 generations backK020929 Smartscore 3.5; Smartscore 4.0; Smartscore 4.5GE Medical Systems · 2002
- 6 generations backK072737 CSCS-001A Calcium Scoring PackageToshiba America Medical Systems, In.C · 2007
- 5 generations backK083446 Cardiac Function Analysis, Calcium ScoringZiosoft, Inc. · 2009
- 4 generations backK111373 CT42 Cardiac Computed Tomography (CT) SoftwareCircle Cardiovascular Imaging, Inc. · 2011
- 3 generations backK203256 Imbio RV/LV SoftwareImbio, LLC · 2021
- 2 generations backK221100 Viz RV/LVViz. Ai, Inc. · 2022
- 1 generation backK230534 BriefCase-QuantificationAidoc Medical, Ltd. · 2023
- This deviceK243779 Bunkerhill Abdominal Aortic Quantification (AAQ)BunkerHill Health · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K945512 | HRSW Option for CT Twin Flash | Elscint, Inc. | 1995 | — |
| −9 | K970980 | Cardiac Scoring for CT Scanners | Elscint, Inc. | 1997 | — |
| −8 | K982004 | CT Coronary Artery Calcification Scoring (Cacs) Option for Advantage Windows | General Electric Co. | 1998 | — |
| −7 | K020929 | Smartscore 3.5; Smartscore 4.0; Smartscore 4.5 | GE Medical Systems | 2002 | — |
| −6 | K072737 | CSCS-001A Calcium Scoring Package | Toshiba America Medical Systems, In.C | 2007 | — |
| −5 | K083446 | Cardiac Function Analysis, Calcium Scoring | Ziosoft, Inc. | 2009 | — |
| −4 | K111373 | CT42 Cardiac Computed Tomography (CT) Software | Circle Cardiovascular Imaging, Inc. | 2011 | — |
| −3 | K203256 | Imbio RV/LV Software | Imbio, LLC | 2021 | — |
| −2 | K221100 | Viz RV/LV | Viz. Ai, Inc. | 2022 | — |
| −1 | K230534 | BriefCase-Quantification | Aidoc Medical, Ltd. | 2023 | — |
| 0 (this device) | K243779 | Bunkerhill Abdominal Aortic Quantification (AAQ) | BunkerHill Health | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
| 2002 | 2 | 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 |
|---|---|---|---|
| * | K230534 | BriefCase-QuantificationSummary page 5…QIH Regulatory Class II Predicate Device Proprietary Name Briefcase Quantification Device Premarket Notification K230534 Classification Name Medical image management and processing system Regulation Number 21 CFR 892… | 2023 |
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 30 years and passes through 10 companies; a new generation was cleared every 2.2 years on median.
- None of the 19 ancestors has a recall.
- 1 other device also cites its predicate K230534.
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?
Bunkerhill AAQ is a radiological image processing system software indicated for use in the analysis of CT exams with or without contrast, that include the L1 — L5 region of the abdominal aorta, in adults aged 22 and older. The device is intended to assist appropriately trained medical specialists by providing the user with the maximum axial abdominal aortic axial diameter measurement of cases that include the abdominal aorta. Bunkerhill AAQ is indicated…
Read the full statement (155 words)
Bunkerhill AAQ is a radiological image processing system software indicated for use in the analysis of CT exams with or without contrast, that include the L1 — L5 region of the abdominal aorta, in adults aged 22 and older.
The device is intended to assist appropriately trained medical specialists by providing the user with the maximum axial abdominal aortic axial diameter measurement of cases that include the abdominal aorta. Bunkerhill AAQ is indicated to evaluate normal and aneurysmal abdominal aortas and is not intended to evaluate post-operative aortas.
The Bunkerhill AAQ results are not intended to be used on a stand-alone basis for clinical decision-making or otherwise preclude clinical assessment of cases. These measurements are unofficial, are not final, and are subject to change after review by a qualified interpreting physician. For final clinically approved measurements, please refer to the official radiology report. Clinicians are responsible for viewing full images per the standard of care.
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/K243779 · printed Nov 6, 2026
Cite this page
510(k) Report. “K243779: Bunkerhill Abdominal Aortic Quantification (AAQ).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K243779
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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