510(k) · Cleared
ClearedAutoChamber
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
HeartLung Corporation · QIH Automated Radiological Image Processing Software
Cleared on Oct 10, 2024 as substantially equivalent to K203256 (Imbio, LLC, 2021) and 1 other predicate after a 202-day review. Its family tree reaches back 10 generations to 1991. 1 later device descends from it.
- Decided
- Oct 10, 2024
- Review
- 202 days
- Class
- Class II
- Product code
- QIH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 10 generations to K913770 (1991). 73 ancestors in all, the oldest K871859 (1987). 1 later device descends from it, 1 citing it directly.
- Root · 10 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 6 generations between
- 3 generations backK052632 VITREA2 Version 3.8 Medical Image Processing SoftwareVital Images, Inc. · 2005 · Recalled
- 2 generations backK061624 Vitrea, Version 3.9Vital Images, Inc. · 2006 · Recalled
- 1 generation backK092747 Philips Comprehensive Cardiac Analysis (Cca) - Plaque Assessment ToolPhilips Medical Systems (Cleveland), Inc. · 2009
- This deviceK240786 AutoChamberHeartLung Corporation · 2024
- Descendant · cites it directly · 0 of its ownK252029 AI-CVDHeartLung Corporation · 2025
Show all 10 generations
- Root · 10 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 9 generations backK960613 GE Advantage Windows Review WorkstationGE Medical Systems · 1996
- 8 generations backK020483 Advantage Workstation 4.1GE Medical Systems · 2002 · Recalled
- 7 generations backK023003 Imagechecker-CT WorkstationR2 Technology, Inc. · 2002
- 6 generations backK032748 VITREA2, Version 3.4 Medical Image Processing SoftwareVital Images, Inc. · 2003 · Recalled
- 5 generations backK040305 VITREA2 Version 3.5Vital Images, Inc. · 2004
- 4 generations backK043333 VITREA2, Version 3.7 Medical Image Processing SystemVital Images, Inc. · 2004 · Recalled
- 3 generations backK052632 VITREA2 Version 3.8 Medical Image Processing SoftwareVital Images, Inc. · 2005 · Recalled
- 2 generations backK061624 Vitrea, Version 3.9Vital Images, Inc. · 2006 · Recalled
- 1 generation backK092747 Philips Comprehensive Cardiac Analysis (Cca) - Plaque Assessment ToolPhilips Medical Systems (Cleveland), Inc. · 2009
- This deviceK240786 AutoChamberHeartLung Corporation · 2024
Most influential descendants
Showing 1 of 1 · See all- K252029AI-CVDHeartLung Corporation · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K913770 | Advantage V.S. CT/MR Rad Diagnostic Workstation | General Electric Co. | 1991 | — |
| −9 | K960613 | GE Advantage Windows Review Workstation | GE Medical Systems | 1996 | — |
| −8 | K020483 | Advantage Workstation 4.1 | GE Medical Systems | 2002 | 2 |
| −7 | K023003 | Imagechecker-CT Workstation | R2 Technology, Inc. | 2002 | — |
| −6 | K032748 | VITREA2, Version 3.4 Medical Image Processing Software | Vital Images, Inc. | 2003 | 2 |
| −5 | K040305 | VITREA2 Version 3.5 | Vital Images, Inc. | 2004 | — |
| −4 | K043333 | VITREA2, Version 3.7 Medical Image Processing System | Vital Images, Inc. | 2004 | 1 |
| −3 | K052632 | VITREA2 Version 3.8 Medical Image Processing Software | Vital Images, Inc. | 2005 | 2 |
| −2 | K061624 | Vitrea, Version 3.9 | Vital Images, Inc. | 2006 | 1 |
| −1 | K092747 | Philips Comprehensive Cardiac Analysis (Cca) - Plaque Assessment Tool | Philips Medical Systems (Cleveland), Inc. | 2009 | — |
| 0 (this device) | K240786 | AutoChamber | HeartLung Corporation | 2024 | — |
| +1 | K252029 | AI-CVD | HeartLung Corporation | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1993 | 3 | 0 |
| 1994 | 4 | 0 |
| 1995 | 3 | 0 |
| 1996 | 5 | 0 |
| 1997 | 5 | 0 |
| 1998 | 5 | 0 |
| 1999 | 4 | 0 |
| 2000 | 4 | 0 |
| 2001 | 7 | 0 |
| 2002 | 7 | 0 |
| 2003 | 2 | 0 |
| 2004 | 4 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 3 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2021 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 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 23.6 · 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? (2)
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 |
|---|---|---|---|
| * | K203256 | Imbio RV/LV SoftwareSummary page 5…ode: QIH 510(k) #: K240786 3. Predicate Device Manufacturer: Imbio (Minneapolis, MN), LLC Trade Name: Imbio RV/LV Software Predicate 510(k): K203256 4. Reference Device Manufacturer: Philips Medical Systems, (Cleveland), Inc. Trade Name: Philips Comprehensive Ca… | 2021 |
| * | K092747 | Philips Comprehensive Cardiac Analysis (Cca) - Plaque Assessment ToolSummary page 5…Manufacturer: Philips Medical Systems, (Cleveland), Inc. Trade Name: Philips Comprehensive Cardiac Analysis (CCA) Plaque Assessment Tool Reference 510(k): K092747 5. Device Description General Description The AutoChamber Software is an opportunistic AI-powered quantitative imaging tool… | 2009 |
| † | K060937 | Brilliance Volume | 2006 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K252029 | AI-CVD | 2025 | 0 |
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 6 companies; a new generation was cleared every 12 months on median.
- 14 of the 73 ancestors have a recall of any class.
- Of its descendants, K252029 (HeartLung Corporation, 2025) has gone furthest, with 0 descendants of its own.
- 5 other devices also cite its predicate K203256.
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?
The AutoChamber software is an opportunistic AI-powered quantitative imaging tool that measures and reports cardiac chambers volumes comprising left atrium (LA), left ventricle (LV), right atrium (RA), right ventricle (RV), and left ventricular wall (LVW) from non-contrast chest CT scans including coronary artery calcium (CAC) scans and lung CT scans. AutoChamber is not intended to rule out the risk of a cardiovascular disease, and the results should not…
Read the full statement (308 words)
The AutoChamber software is an opportunistic AI-powered quantitative imaging tool that measures and reports cardiac chambers volumes comprising left atrium (LA), left ventricle (LV), right atrium (RA), right ventricle (RV), and left ventricular wall (LVW) from non-contrast chest CT scans including coronary artery calcium (CAC) scans and lung CT scans. AutoChamber is not intended to rule out the risk of a cardiovascular disease, and the results should not be used for any purpose other than to enable physicians to investigate patients that AutoChamber shows signs of enlarged heart (cardiomegaly), enlarged cardiac chambers, and left ventricular hypertrophy (LVH) whose conditions are otherwise missed by human eyes in non-contrast chest CT scans. AutoChamber similarly measures and reports LA, LV, RA, RV, and LVW in contrast-enhanced coronary CT angiography (CCTA) scans. Additionally, AutoChamber measures and reports cardiothoracic ratio (CTR) in both contrast and non-contrast CT scans where the entire thoracic cavity is in the axial field of view. AutoChamber quantitative imaging measurements are adjusted by body surface area (BSA) and are reported both in cubic centimeter volume (cc) and percentiles by gender using reference data from 5830 people who participated in the Multi-Ethnic Study of Atherosclerosis (MESA). AutoChamber should not be ordered as a standalone CT scan but instead should be used as an opportunistic add-on to existing and new CT scans of the chest, such as CAC and lung CT scans, as well as CCTA scans.
Using AutoChamber quantitative imaging measurements and their clinical evaluation, healthcare providers can investigate asymptomatic patients who are unaware of their risk of heart failure, atrial fibrillation, stroke and other life-threatening conditions associated with enlarged heart, enlarged cardiac chambers, and LVH that may warrant additional risk-assessment or follow-up. AutoChamber quantitative imaging measurements are to be reviewed by radiologists or other medical professionals and should only be used by healthcare providers in conjunction with clinical evaluation.
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/K240786 · printed Nov 4, 2026
Cite this page
510(k) Report. “K240786: AutoChamber.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K240786
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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