510(k) · Cleared
ClearedImbio RV/LV Software
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Imbio, LLC · QIH Automated Radiological Image Processing Software
Cleared on Mar 9, 2021 as substantially equivalent to K111373 (Circle Cardiovascular Imaging, Inc., 2011) after a 125-day review. Its family tree reaches back 7 generations to 1995. 17 later devices descend from it.
- Decided
- Mar 9, 2021
- Review
- 125 days
- Class
- Class II
- Product code
- QIH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K945512 (1995). 16 ancestors in all, the oldest K945428 (1995). 17 later devices descend from it, 6 citing it directly.
- Root · 7 generations backK945512 HRSW Option for CT Twin FlashElscint, Inc. · 1995
- 6 generations backK970980 Cardiac Scoring for CT ScannersElscint, Inc. · 1997
- 5 generations backK982004 CT Coronary Artery Calcification Scoring (Cacs) Option for Advantage…General Electric Co. · 1998
- 4 generations backK020929 Smartscore 3.5; Smartscore 4.0; Smartscore 4.5GE Medical Systems · 2002
- 3 generations backK072737 CSCS-001A Calcium Scoring PackageToshiba America Medical Systems, In.C · 2007
- 2 generations backK083446 Cardiac Function Analysis, Calcium ScoringZiosoft, Inc. · 2009
- 1 generation backK111373 CT42 Cardiac Computed Tomography (CT) SoftwareCircle Cardiovascular Imaging, Inc. · 2011
- This deviceK203256 Imbio RV/LV SoftwareImbio, LLC · 2021
- Descendant · cites it directly · 4 of its ownK221100 Viz RV/LVViz. Ai, Inc. · 2022
- Descendant · 2 generations on · 3 of its ownK230534 BriefCase-QuantificationAidoc Medical, Ltd. · 2023
- Descendant · cites it directly · 3 of its ownK212624 EFAI Intelligent Cardiothoracic Ratio (iCTR) Assessment SystemEver Fortune.Ai, Co., Ltd. · 2022
- Descendant · cites it directly · 2 of its ownK220624 AI4CMR v1.0Ai4medimaging Medical Solutions S.A. · 2022
- Descendant · cites it directly · 1 of its ownK240786 AutoChamberHeartLung Corporation · 2024
Showing 5 of 17 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 17 · See all- K221100Viz RV/LVViz. Ai, Inc. · 2022 · cites it directly4descendants
- K230534BriefCase-QuantificationAidoc Medical, Ltd. · 2023 · 2 generations on3descendants
- K212624EFAI Intelligent Cardiothoracic Ratio (iCTR) Assessment SystemEver Fortune.Ai, Co., Ltd. · 2022 · cites it directly3descendants
- K220624AI4CMR v1.0Ai4medimaging Medical Solutions S.A. · 2022 · cites it directly2descendants
- K240786AutoChamberHeartLung Corporation · 2024 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K945512 | HRSW Option for CT Twin Flash | Elscint, Inc. | 1995 | — |
| −6 | K970980 | Cardiac Scoring for CT Scanners | Elscint, Inc. | 1997 | — |
| −5 | K982004 | CT Coronary Artery Calcification Scoring (Cacs) Option for Advantage Windows | General Electric Co. | 1998 | — |
| −4 | K020929 | Smartscore 3.5; Smartscore 4.0; Smartscore 4.5 | GE Medical Systems | 2002 | — |
| −3 | K072737 | CSCS-001A Calcium Scoring Package | Toshiba America Medical Systems, In.C | 2007 | — |
| −2 | K083446 | Cardiac Function Analysis, Calcium Scoring | Ziosoft, Inc. | 2009 | — |
| −1 | K111373 | CT42 Cardiac Computed Tomography (CT) Software | Circle Cardiovascular Imaging, Inc. | 2011 | — |
| 0 (this device) | K203256 | Imbio RV/LV Software | Imbio, LLC | 2021 | — |
| +1 | K221100 | Viz RV/LV | Viz. Ai, Inc. | 2022 | — |
| +2 | K230534 | BriefCase-Quantification | Aidoc Medical, Ltd. | 2023 | — |
| +1 | K212624 | EFAI Intelligent Cardiothoracic Ratio (iCTR) Assessment System | Ever Fortune.Ai, Co., Ltd. | 2022 | — |
| +1 | K220624 | AI4CMR v1.0 | Ai4medimaging Medical Solutions S.A. | 2022 | — |
| +1 | K240786 | AutoChamber | HeartLung Corporation | 2024 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 3 | 0 |
| 2023 | 3 | 0 |
| 2024 | 6 | 0 |
| 2025 | 4 | 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 |
|---|---|---|---|
| * | K111373 | CT42 Cardiac Computed Tomography (CT) SoftwareSummary page 4…vice To Which The Device Is Substantially Equivalent The RV/LV Software is substantially equivalent to the ct42 Cardiac Computed Tomography Software cleared under K111373. I.7 Description of the Device The Imbio CT RV/LV Software is a set of medical image post-processing computer algo- rithms th… | 2011 |
What descends from it? (17)
See all 176 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 26 years and passes through 7 companies; a new generation was cleared every 2.4 years on median.
- None of the 16 ancestors has a recall.
- Of its descendants, K221100 (Viz. Ai, Inc., 2022) has gone furthest, with 4 descendants of its own.
- 2 other devices also cite its predicate K111373.
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. 2021, 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 Imbio RV/LV Software device is designed to measure the maximal diameters of the right and left ventricles of the heart from a volumetric CTPA acquisition and report the ratio of those measurements. RV/LV analyzes cases using an artificial intelligence algorithm to identify the location and measurements of the ventricles. The RV/LV software provides the user with annotated images showing ventricular measurements. Its results are not intended to be used on a stand-alone basis for clinical decision-making or otherwise preclude clinical assessment of CTPA cases.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K203256 · printed Nov 5, 2026
Cite this page
510(k) Report. “K203256: Imbio RV/LV Software.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K203256
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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