# K223855: FEops HEARTguideTM, FEops HEARTguideTM ALPACA

- Pathway: 510(k) (Traditional)
- Applicant: Feops NV
- Decided: Jun 6, 2023 after 165 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: 7 generations back to K954678 (1996). 19 ancestors in all.
No later device cites it as a predicate yet.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K153736: 3mensio Workstation, Pie Medical Imaging BV (2016) Summary page 4.

## Indications for use
FEops HEARTguide™ ALPACA enables visualization and measurement of structures of the heart and vessels for preprocedural planning and sizing of structural heart interventions. To facilitate the above, FEops HEARTguide™ ALPACA provides general functionality such as: • Segmentation of cardiovascular structures • Visualization and image reconstruction techniques: 2D review, MPR • Measurement and annotation tools • Reporting tools FEops HEARTguide™ ALPACA also allows visualization of output generated by other medical device software (e.g., FEops HEARTguide™ Simulation Application cleared as K214066). 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. FEops HEARTguide™ ALPACA is not intended to replace the implant device instructions for use for final LAAO and TAVI device selection and placement.

Source page: https://510kreport.com/device/K223855
Methodology: https://510kreport.com/methodology