# K260300: WatchMate Software

- Pathway: 510(k) (Traditional)
- Applicant: Anumana, Inc.
- Decided: Jun 15, 2026 after 136 days
- Product code: QIH (Automated Radiological Image Processing Software)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K954678 (1996). 21 ancestors in all.
No later device cites it as a predicate yet.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K222593: TruPlan Computed Tomography (CT) Imaging Software, Circle Cardiovascular Imaging, Inc. (2023) Summary page 5.

## Indications for use
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.

Source page: https://510kreport.com/device/K260300
Methodology: https://510kreport.com/methodology