FEops HEARTguideTM, FEops HEARTguideTM ALPACA
K223855FEops nv · cleared 2023-06-06 · product code QIH · Radiology
Premarket evidence — what FDA accepted
Device typesamd
source quote (p.5)
“The software is used in a service-based business model: the customer (clinician) provides the necessary input data, FEops prepares the anatomical analysis, and delivers the results to the customer.”
Algorithmartificial intelligence including nonadaptive machine learning algorithms
source quote (p.6)
“Similar, the subject device implements artificial intelligence including nonadaptive machine learning algorithms”
Adaptive (vs locked)No
source quote (p.6)
“Similar, the subject device implements artificial intelligence including nonadaptive machine learning algorithms”
PCCPFDA source did not state this
Cybersecurity addressedYes
source quote (p.11)
“FEops HEARTguide™ ALPACA is subject to cybersecurity measures (see Section 16).”
Validation studies (2)
Retrospective clinical
n=35 cases
endpoints: mean diameter of the semi-automatically identified landing zone
Retrospective clinical
n=35 cases
endpoints: perimeter-based diameter of the semi-automatically identified aortic annulus
Reported performance (16 observations)
diceas written: “Mean dice score - Semi-automatic output (LAAO)”0.98CI ± 0.01
source quote (p.13)
“Mean dice score 0.98 ± 0.01”
diceas written: “Minimum Dice score - Semi-automatic output (LAAO)”0.95
source quote (p.13)
“Minimum Dice score 0.95”
diceas written: “Maximum Dice score - Semi-automatic output (LAAO)”0.99
source quote (p.13)
“Maximum Dice score 0.99”
diceas written: “Median Dice score - Semi-automatic output (LAAO)”0.98
source quote (p.13)
“Median Dice score 0.98”
diceas written: “Mean dice score - Fully automatic output (LAAO)”0.93CI ± 0.04
source quote (p.13)
“Mean dice score 0.93 ± 0.04”
diceas written: “Minimum Dice score - Fully automatic output (LAAO)”0.83
source quote (p.13)
“Minimum Dice score 0.83”
diceas written: “Maximum Dice score - Fully automatic output (LAAO)”0.97
source quote (p.13)
“Maximum Dice score 0.97”
diceas written: “Median Dice score - Fully automatic output (LAAO)”0.94
source quote (p.13)
“Median Dice score 0.94”
diceas written: “Mean dice score - Semi-automatic output (TAVI)”0.97CI ± 0.01
source quote (p.14)
“Mean dice score 0.97 ± 0.01”
diceas written: “Minimum Dice score - Semi-automatic output (TAVI)”0.92
source quote (p.14)
“Minimum Dice score 0.92”
diceas written: “Maximum Dice score - Semi-automatic output (TAVI)”0.99
source quote (p.14)
“Maximum Dice score 0.99”
diceas written: “Median Dice score - Semi-automatic output (TAVI)”0.97
source quote (p.14)
“Median Dice score 0.97”
diceas written: “Mean dice score - Fully automatic output (TAVI)”0.96CI ± 0.01
source quote (p.14)
“Mean dice score 0.96 ± 0.01”
diceas written: “Minimum Dice score - Fully automatic output (TAVI)”0.92
source quote (p.14)
“Minimum Dice score 0.92”
diceas written: “Maximum Dice score - Fully automatic output (TAVI)”0.98
source quote (p.14)
“Maximum Dice score 0.98”
diceas written: “Median Dice score - Fully automatic output (TAVI)”0.96
source quote (p.14)
“Median Dice score 0.96”
Each value carries its own analysis unit and task — never compare or pool across devices. Source: 510(k) summary PDF.
Predicate network
Postmarket — what happened after clearance
0
recalls in product code, 24mo
3
MAUDE reports in code, 12mo
—
vs code's own 3-yr baseline
0
drift signals on this device
Recall and MAUDE counts are product-code-level (reports aren't reliably attributable to one device). Signals are descriptive observables with sources — never a judgment that the device is unsafe or drifting. Snapshot 2026-07-08.
Reimbursement — how devices like this got paid
Not yet tracked — no payment pathway indexed for this clearance (the reimbursement corpus is a growing seed set).