510(k) · Cleared
ClearedWatchMate Software
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Anumana, Inc. · QIH Automated Radiological Image Processing Software
Cleared on Jun 15, 2026 as substantially equivalent to K222593 (Circle Cardiovascular Imaging, Inc., 2023) after a 136-day review. Its family tree reaches back 9 generations to 1996.
- Decided
- Jun 15, 2026
- Review
- 136 days
- Class
- Class II
- Product code
- QIH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K954678 (1996). 21 ancestors in all, the oldest K954668 (1995). No later device cites it as a predicate yet.
- Root · 9 generations backK954678 Pro VisionAlgotec Systems, Ltd. · 1996
- 5 generations between
- 3 generations backK153736 3mensio WorkstationPie Medical Imaging BV · 2016 · Recalled
- 2 generations backK202212 TruPlanCircle Cardiovascular Imaging, Inc. · 2021
- 1 generation backK222593 TruPlan Computed Tomography (CT) Imaging SoftwareCircle Cardiovascular Imaging, Inc. · 2023
- This deviceK260300 WatchMate SoftwareAnumana, Inc. · 2026
Show all 9 generations
- Root · 9 generations backK954678 Pro VisionAlgotec Systems, Ltd. · 1996
- 8 generations backK980648 Pro VisionAlgotec Systems, Ltd. · 1998
- 7 generations backK992654 Plug 'N View 3D, Version 1.0Voxar Limited · 1999
- 6 generations backK043097 3VISEON3Mensio Medical Imaging BV · 2004
- 5 generations backK072653 3VISEON/Surgery3Mensio Medical Imaging BV · 2008
- 4 generations backK120367 3MENSIO WorkstationPie Medical Imaging BV · 2012
- 3 generations backK153736 3mensio WorkstationPie Medical Imaging BV · 2016 · Recalled
- 2 generations backK202212 TruPlanCircle Cardiovascular Imaging, Inc. · 2021
- 1 generation backK222593 TruPlan Computed Tomography (CT) Imaging SoftwareCircle Cardiovascular Imaging, Inc. · 2023
- This deviceK260300 WatchMate SoftwareAnumana, Inc. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K954678 | Pro Vision | Algotec Systems, Ltd. | 1996 | — |
| −8 | K980648 | Pro Vision | Algotec Systems, Ltd. | 1998 | — |
| −7 | K992654 | Plug 'N View 3D, Version 1.0 | Voxar Limited | 1999 | — |
| −6 | K043097 | 3VISEON | 3Mensio Medical Imaging BV | 2004 | — |
| −5 | K072653 | 3VISEON/Surgery | 3Mensio Medical Imaging BV | 2008 | — |
| −4 | K120367 | 3MENSIO Workstation | Pie Medical Imaging BV | 2012 | — |
| −3 | K153736 | 3mensio Workstation | Pie Medical Imaging BV | 2016 | 1 |
| −2 | K202212 | TruPlan | Circle Cardiovascular Imaging, Inc. | 2021 | — |
| −1 | K222593 | TruPlan Computed Tomography (CT) Imaging Software | Circle Cardiovascular Imaging, Inc. | 2023 | — |
| 0 (this device) | K260300 | WatchMate Software | Anumana, Inc. | 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 |
|---|---|---|---|
| * | K222593 | TruPlan Computed Tomography (CT) Imaging SoftwareSummary page 5…atchMate TEE PREDICATE DEVICE(S) [807.92(A)(3)] • Predicate Device: Circle Cardiovascular Imaging, Inc. - TruPlan Computed Tomography (CT) Imaging Software (K222593) • Reference Device 1: Philips Ultrasound, Inc. - 3D Auto LAA (K201352) • Reference Device 2: Nesa Medtech Private Limi… | 2023 |
| † | K201352 | 3D Auto LAA | 2020 |
| † | K222683 | Fibroid Mapping Reviewer Application (FMRA) | 2023 |
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 6 companies; a new generation was cleared every 3.4 years on median.
- 5 of the 21 ancestors have a recall of any class.
- 1 other device also cites its predicate K222593.
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?
WatchMate Software enables visualization and measurement of structures of the heart and vessels for preprocedural planning and sizing for the left atrial appendage closure (LAAC) procedure. To facilitate the above, WatchMate Software provides general functionality such as: 3D reconstruction of the left atrial appendage (LAA) from transesophageal echocardiogram images of the left atrial appendage Visualization and image reconstruction, including 2D review…
Read the full statement (107 words)
WatchMate Software enables visualization and measurement of structures of the heart and vessels for preprocedural planning and sizing for the left atrial appendage closure (LAAC) procedure.
To facilitate the above, WatchMate Software provides general functionality such as:
3D reconstruction of the left atrial appendage (LAA) from transesophageal echocardiogram images of the left atrial appendage
Visualization and image reconstruction, including 2D review and 3D rendering
Measurement and annotation tools
The results are intended to be used by qualified clinicians in conjunction with the patient's clinical history, symptoms, and other preprocedural evaluations, as well as the clinician's professional judgment.
WatchMate Software’s intended patient population is comprised of adult patients.
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/K260300 · printed Nov 6, 2026
Cite this page
510(k) Report. “K260300: WatchMate Software.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K260300
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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