510(k) · Cleared
ClearedHi-D Imaging 4TAVR
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hi-D Imaging AG · QIH Automated Radiological Image Processing Software
Cleared on Jul 20, 2026 as substantially equivalent to K241984 (Hi-D Imaging AG, 2025) after a 73-day review. Its family tree reaches back 8 generations to 1996.
- Decided
- Jul 20, 2026
- Review
- 73 days
- Class
- Class II
- Product code
- QIH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K954678 (1996). 20 ancestors in all, the oldest K954668 (1995). No later device cites it as a predicate yet.
- Root · 8 generations backK954678 Pro VisionAlgotec Systems, Ltd. · 1996
- 7 generations backK980648 Pro VisionAlgotec Systems, Ltd. · 1998
- 6 generations backK992654 Plug 'N View 3D, Version 1.0Voxar Limited · 1999
- 5 generations backK043097 3VISEON3Mensio Medical Imaging BV · 2004
- 4 generations backK072653 3VISEON/Surgery3Mensio Medical Imaging BV · 2008
- 3 generations backK120367 3MENSIO WorkstationPie Medical Imaging BV · 2012
- 2 generations backK153736 3mensio WorkstationPie Medical Imaging BV · 2016 · Recalled
- 1 generation backK241984 Hi-D Imaging 4TAVRHi-D Imaging AG · 2025
- This deviceK261535 Hi-D Imaging 4TAVRHi-D Imaging AG · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K954678 | Pro Vision | Algotec Systems, Ltd. | 1996 | — |
| −7 | K980648 | Pro Vision | Algotec Systems, Ltd. | 1998 | — |
| −6 | K992654 | Plug 'N View 3D, Version 1.0 | Voxar Limited | 1999 | — |
| −5 | K043097 | 3VISEON | 3Mensio Medical Imaging BV | 2004 | — |
| −4 | K072653 | 3VISEON/Surgery | 3Mensio Medical Imaging BV | 2008 | — |
| −3 | K120367 | 3MENSIO Workstation | Pie Medical Imaging BV | 2012 | — |
| −2 | K153736 | 3mensio Workstation | Pie Medical Imaging BV | 2016 | 1 |
| −1 | K241984 | Hi-D Imaging 4TAVR | Hi-D Imaging AG | 2025 | — |
| 0 (this device) | K261535 | Hi-D Imaging 4TAVR | Hi-D Imaging AG | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2004 | 2 | 0 |
| 2006 | 2 | 0 |
| 2015 | 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 |
|---|---|---|---|
| * | K241984 | Hi-D Imaging 4TAVRSummary page 5…Hi-D Imaging 4TAVR Generic/Common Name: Automated Radiological Image Processing Software PREDICATE DEVICE(S) [807.92(A)(3)] Hi-D Imaging 4TAVR v1.14.1_a (K241984) DEVICE DESCRIPTION [807.92(A)(4)] Hi-D Imaging 4TAVR (“the Device” or “4TAVR”) is a cloud-based software as a medical device (S… | 2025 |
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 5 companies; a new generation was cleared every 4.1 years on median.
- 5 of the 20 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. 2026, 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?
Hi-D Imaging 4TAVR is a software as a medical device (SaMD) intended to support trained healthcare professionals (cardiologists, radiologists, clinical specialists) with the assessment of the cardiovascular anatomy and visualization and measurement of structures of the heart and vessels, including the aortic valve and femoral arteries, and with pre-procedural planning and sizing for transcatheter aortic valve replacement (TAVR) procedures by providing: *…
Read the full statement (179 words)
Hi-D Imaging 4TAVR is a software as a medical device (SaMD) intended to support trained healthcare professionals (cardiologists, radiologists, clinical specialists) with the assessment of the cardiovascular anatomy and visualization and measurement of structures of the heart and vessels, including the aortic valve and femoral arteries, and with pre-procedural planning and sizing for transcatheter aortic valve replacement (TAVR) procedures by providing:
* Automatic segmentation of the full heart and vessels;
» 3D and 2D rendering of DICOM images;
» Automatic centerline detection;
» Automatic detection of the LVOT (left ventricular outflow tract), aortic, sinus, sinotubular junction (STJ), ascending aorta and descending aorta planes;
» Automatic detection of abdominal aorta, left and right common iliac, left and right external iliac, left and right femoral artery planes;
» Automatic multiplanar reconstruction (MPR) based on the centerline;
* Measurement and visualization tools;
» Manual measurement option for the user;
» Automatic S-curve extraction;
» Automatic report generation;
Hi-D Imaging 4TAVR software is indicated for patients with tricuspid aortic stenosis who are eligible for TAVR operations and without any prior aortic valve implants.
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/K261535 · printed Nov 6, 2026
Cite this page
510(k) Report. “K261535: Hi-D Imaging 4TAVR.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K261535
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026