510(k) · Cleared
Recalled · Class II · 2021Caption Interpretation Automated Ejection Fraction Software
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Caption Health · QIH Automated Radiological Image Processing Software
Cleared on Jul 22, 2020 as substantially equivalent to K173780 (Bay Labs, Inc., 2018) after a 135-day review. Its family tree reaches back 13 generations to 1995. 3 later devices descend from it. It has been recalled once.
- Decided
- Jul 22, 2020
- Review
- 135 days
- Class
- Class II
- Product code
- QIH
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 13 generations to K935595 (1995). 51 ancestors in all, the oldest K921148 (1992). 3 later devices descend from it, 1 citing it directly.
- Root · 13 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 9 generations between
- 3 generations backK072090 Siemens Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc., Ultrasound DI · 2007
- 2 generations backK130779 Lvivo EF SystemDiacardio, Ltd. · 2013
- 1 generation backK173780 EchoMD Automated Ejection Fraction SoftwareBay Labs, Inc. · 2018
- This deviceK200621 Caption Interpretation Automated Ejection Fraction SoftwareCaption Health · 2020
- Descendant · cites it directly · 2 of its ownK210747 Caption Interpretation Automated Ejection Fraction SoftwareCaption Health · 2022
- Descendant · 2 generations on · 0 of its ownK253593 Clarius Ejection Fraction AIClarius Mobile Health Corp. · 2026
- Descendant · 2 generations on · 0 of its ownK232331 InVision Precision LVEF (LVEF)InVision Medical Technology Corporation · 2024
Show all 13 generations
- Root · 13 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 12 generations backK973767 Harmonic Imaging with ContrastAcuson Corp. · 1997
- 11 generations backK022567 Sequoia Signature II Diagnostic Ultrasound SystemAcuson Corp. · 2002
- 10 generations backK032114 Sequoia 8.0 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2003
- 9 generations backK041319 Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2004
- 8 generations backK042770 Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2004 · Recalled
- 7 generations backK050240 Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
- 6 generations backK052894 Sonoline G60 S Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
- 5 generations backK061946 Acuson X300 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2006 · Recalled
- 4 generations backK071036 Modification to Acuson X300 Ultrasound SystemSiemens Medical Solutions USA, Inc., Ultrasound DI · 2007
- 3 generations backK072090 Siemens Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc., Ultrasound DI · 2007
- 2 generations backK130779 Lvivo EF SystemDiacardio, Ltd. · 2013
- 1 generation backK173780 EchoMD Automated Ejection Fraction SoftwareBay Labs, Inc. · 2018
- This deviceK200621 Caption Interpretation Automated Ejection Fraction SoftwareCaption Health · 2020
Most influential descendants
Showing 3 of 3 · See all- K210747Caption Interpretation Automated Ejection Fraction SoftwareCaption Health · 2022 · cites it directly2descendants
- K253593Clarius Ejection Fraction AIClarius Mobile Health Corp. · 2026 · 2 generations on0descendants
- K232331InVision Precision LVEF (LVEF)InVision Medical Technology Corporation · 2024 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K935595 | Acuson Model 3001 | Acuson Corp. | 1995 | — |
| −12 | K973767 | Harmonic Imaging with Contrast | Acuson Corp. | 1997 | — |
| −11 | K022567 | Sequoia Signature II Diagnostic Ultrasound System | Acuson Corp. | 2002 | — |
| −10 | K032114 | Sequoia 8.0 Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2003 | — |
| −9 | K041319 | Sequoia Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2004 | — |
| −8 | K042770 | Modification to Acuson CV70 Cardiovascular System | Siemens Medical Solutions USA, Inc. | 2004 | 1 |
| −7 | K050240 | Modification to Acuson CV70 Cardiovascular System | Siemens Medical Solutions USA, Inc. | 2005 | 1 |
| −6 | K052894 | Sonoline G60 S Ultrasound System | Siemens Medical Solutions USA, Inc. | 2005 | 1 |
| −5 | K061946 | Acuson X300 Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2006 | 1 |
| −4 | K071036 | Modification to Acuson X300 Ultrasound System | Siemens Medical Solutions USA, Inc., Ultrasound DI | 2007 | — |
| −3 | K072090 | Siemens Diagnostic Ultrasound Systems | Siemens Medical Solutions USA, Inc., Ultrasound DI | 2007 | — |
| −2 | K130779 | Lvivo EF System | Diacardio, Ltd. | 2013 | — |
| −1 | K173780 | EchoMD Automated Ejection Fraction Software | Bay Labs, Inc. | 2018 | — |
| 0 (this device) | K200621 | Caption Interpretation Automated Ejection Fraction Software | Caption Health | 2020 | — |
| +1 | K210747 | Caption Interpretation Automated Ejection Fraction Software | Caption Health | 2022 | — |
| +2 | K253593 | Clarius Ejection Fraction AI | Clarius Mobile Health Corp. | 2026 | — |
| +2 | K232331 | InVision Precision LVEF (LVEF) | InVision Medical Technology Corporation | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 4 | 0 |
| 1997 | 2 | 0 |
| 1999 | 4 | 0 |
| 2000 | 5 | 0 |
| 2001 | 2 | 0 |
| 2002 | 2 | 0 |
| 2003 | 3 | 0 |
| 2004 | 8 | 0 |
| 2005 | 3 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2024 | 1 | 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 23.6 · 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? (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 |
|---|---|---|---|
| * | K173780 | EchoMD Automated Ejection Fraction SoftwareSummary page 4…atory Class: II Product Code: QIH, Automated Radiological Image Processing Software Predicate Device Bay Labs, Inc. EchoMD Automated Ejection Fraction Software (K173780) Device Description The Caption Interpretation Automated Ejection Fraction Software applies machine learning algorithms to proc… | 2018 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K210747 | Caption Interpretation Automated Ejection Fraction Software | 2022 | 2 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 19, 2021 | Class II | Z-2111-2021 | Software design | The firm is aware of a issue with ultrasound software that results in unintended video frames being included. This could lead to an incorrect automated ejection fraction (AutoEF) and image quality score (IQS) estimates. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 25 years and passes through 6 companies; a new generation was cleared every 11 months on median.
- 12 of the 51 ancestors have a recall of any class.
- Of its descendants, K210747 (Caption Health, 2022) has gone furthest, with 2 descendants of its own.
- 2 other devices also cite its predicate K173780.
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. 2020, 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 Caption Interpretation Automated Ejection Fraction software is used to process previously acquired
transthoracic cardiac ultrasound images, to store images, and to manipulate and make measurements on
images using an ultrasound device, personal computer, or a compatible DICOM-compliant PACS system in
order to provide automated estimation of left ventricular ejection fraction. This measurement can be used to
assist the clinician in a cardiac evaluation.
The Caption Interpretation Automated Ejection Fraction Software is indicated for use in adult patients.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K200621 · printed Nov 4, 2026
Cite this page
510(k) Report. “K200621: Caption Interpretation Automated Ejection Fraction Software.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K200621
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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