510(k) · Cleared
ClearedinHEART Models
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Inheart, Sas · QIH Automated Radiological Image Processing Software
Cleared on Feb 29, 2024 as substantially equivalent to K220727 (Inheart, Sas, 2022) after a 265-day review. Its family tree reaches back 15 generations to 1991.
- Decided
- Feb 29, 2024
- Review
- 265 days
- Class
- Class II
- Product code
- QIH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 15 generations to K913770 (1991). 69 ancestors in all, the oldest K871859 (1987). No later device cites it as a predicate yet.
- Root · 15 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 11 generations between
- 3 generations backK130383 Synapse 3D Cardiac ToolsFujifilm Medical System U.S.A., Inc. · 2013
- 2 generations backK200973 Synapse 3D Cardiac ToolsFujifilm Corporaton · 2020
- 1 generation backK220727 inHEART MODELSInheart, Sas · 2022
- This deviceK231683 inHEART ModelsInheart, Sas · 2024
Show all 15 generations
- Root · 15 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 14 generations backK960613 GE Advantage Windows Review WorkstationGE Medical Systems · 1996
- 13 generations backK020483 Advantage Workstation 4.1GE Medical Systems · 2002 · Recalled
- 12 generations backK023003 Imagechecker-CT WorkstationR2 Technology, Inc. · 2002
- 11 generations backK032748 VITREA2, Version 3.4 Medical Image Processing SoftwareVital Images, Inc. · 2003 · Recalled
- 10 generations backK040305 VITREA2 Version 3.5Vital Images, Inc. · 2004
- 9 generations backK043333 VITREA2, Version 3.7 Medical Image Processing SystemVital Images, Inc. · 2004 · Recalled
- 8 generations backK052632 VITREA2 Version 3.8 Medical Image Processing SoftwareVital Images, Inc. · 2005 · Recalled
- 7 generations backK061624 Vitrea, Version 3.9Vital Images, Inc. · 2006 · Recalled
- 6 generations backK071331 Vitrea Version 4.0Vital Images, Inc. · 2007 · Recalled
- 5 generations backK073156 Qplaque MRMedis Medical Imaging Systems BV · 2008
- 4 generations backK120636 Synapse 3D Cardiac ToolsFujifilm Medical System U.S.A., Inc. · 2012
- 3 generations backK130383 Synapse 3D Cardiac ToolsFujifilm Medical System U.S.A., Inc. · 2013
- 2 generations backK200973 Synapse 3D Cardiac ToolsFujifilm Corporaton · 2020
- 1 generation backK220727 inHEART MODELSInheart, Sas · 2022
- This deviceK231683 inHEART ModelsInheart, Sas · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −15 | K913770 | Advantage V.S. CT/MR Rad Diagnostic Workstation | General Electric Co. | 1991 | — |
| −14 | K960613 | GE Advantage Windows Review Workstation | GE Medical Systems | 1996 | — |
| −13 | K020483 | Advantage Workstation 4.1 | GE Medical Systems | 2002 | 2 |
| −12 | K023003 | Imagechecker-CT Workstation | R2 Technology, Inc. | 2002 | — |
| −11 | K032748 | VITREA2, Version 3.4 Medical Image Processing Software | Vital Images, Inc. | 2003 | 2 |
| −10 | K040305 | VITREA2 Version 3.5 | Vital Images, Inc. | 2004 | — |
| −9 | K043333 | VITREA2, Version 3.7 Medical Image Processing System | Vital Images, Inc. | 2004 | 1 |
| −8 | K052632 | VITREA2 Version 3.8 Medical Image Processing Software | Vital Images, Inc. | 2005 | 2 |
| −7 | K061624 | Vitrea, Version 3.9 | Vital Images, Inc. | 2006 | 1 |
| −6 | K071331 | Vitrea Version 4.0 | Vital Images, Inc. | 2007 | 1 |
| −5 | K073156 | Qplaque MR | Medis Medical Imaging Systems BV | 2008 | — |
| −4 | K120636 | Synapse 3D Cardiac Tools | Fujifilm Medical System U.S.A., Inc. | 2012 | — |
| −3 | K130383 | Synapse 3D Cardiac Tools | Fujifilm Medical System U.S.A., Inc. | 2013 | — |
| −2 | K200973 | Synapse 3D Cardiac Tools | Fujifilm Corporaton | 2020 | — |
| −1 | K220727 | inHEART MODELS | Inheart, Sas | 2022 | — |
| 0 (this device) | K231683 | inHEART Models | Inheart, Sas | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1993 | 3 | 0 |
| 1994 | 2 | 0 |
| 1995 | 2 | 0 |
| 1996 | 4 | 0 |
| 1997 | 3 | 0 |
| 1998 | 3 | 0 |
| 1999 | 4 | 0 |
| 2000 | 4 | 0 |
| 2001 | 4 | 0 |
| 2002 | 5 | 0 |
| 2003 | 4 | 0 |
| 2004 | 5 | 0 |
| 2005 | 2 | 0 |
| 2006 | 4 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 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 |
|---|---|---|---|
| * | K220727 | inHEART MODELSSummary page 4…roduct Code: Primary product code : QIH Secondary product code : LLZ Regulatory Class: Class II Predicate Device: K220727 – inHEART MODELS, inHEART 510(k) Premarket Notifi… | 2022 |
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 33 years and passes through 8 companies; a new generation was cleared every 11 months on median.
- 10 of the 69 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. 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?
inHEART MODELS comprises a suite of medical imaging software modules that are intended to provide qualified medical professionals with tools to aid them in reading, interpreting, reporting, and treatment planning. inHEART MODELS accepts DICOM compliant medical images acquired from a variety of imaging devices, including CT and MR*. The software is designed to be used by qualified medical professionals (including physicians, cardiologists, radiologists…
Read the full statement (114 words)
inHEART MODELS comprises a suite of medical imaging software modules that are intended to provide qualified medical professionals with tools to aid them in reading, interpreting, reporting, and treatment planning. inHEART MODELS accepts DICOM compliant medical images acquired from a variety of imaging devices, including CT and MR*. The software is designed to be used by qualified medical professionals (including physicians, cardiologists, radiologists, and technicians) and the users are solely responsible for making all final patient management decisions.
* inHEART Models AI software module is indicated for adults only and is designed for CT images only.
CONTRAINDICATIONS:
This product is not intended for use with or for the primary diagnostic interpretation of Mammography images.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K231683 · printed Nov 5, 2026
Cite this page
510(k) Report. “K231683: inHEART Models.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K231683
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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