EchoNavigator R5.0

K253614

Philips Medical Systems Nederland B.V. · cleared 2026-03-17 · product code QIH · Radiology

Premarket evidence — what FDA accepted

Device typesamd

source quote (p.6)

“EchoNavigator is a Software Medical Device that assists the interventionalist and surgeon with image guidance during treatment of cardiovascular disease for which the procedure uses both live X-ray and live Echo guidance.”

AlgorithmArtificial Intelligence which is built with Deep Learning technology

source quote (p.7)

“DeviceGuide offers real-time automatic device detection, tracking and 3D pose-estimation in live Echo and live X-ray enabled by Artificial Intelligence which is built with Deep Learning technology.”

Adaptive (vs locked)No

source quote (p.11)

“To ensure independence between development and testing, testing was performed after algorithm development was completed and the algorithm was frozen.”

PCCPFDA source did not state this

Cybersecurity addressedYes

source quote (p.10)

“Privacy and Security requirements and mitigations have been implemented.”

Validation studies (2)

Standalone

n=72 patients

endpoints: positional accuracy; trajectory/orientation accuracy; algorithm latency

standards: IEC 62304, IEC 62366-1, IEC 82304-1, ISO 14971, ISO 15223-1, ISO 20417:2021, UL ANSI 2900-1, UL ANSI 2900-2-1, IEC 81001-5-1

Reader study (MRMC)

sample size not stated

endpoints: physician assessment of algorithm output sufficiency

Reported performance (3 observations)

accuracyas written: “positional accuracy”stated without value

source quote (p.11)

“Overall performance met predefined specification limits, including ≤5 mm positional accuracy and ≤10° trajectory/orientation accuracy.”

accuracyas written: “trajectory/orientation accuracy”stated without value

source quote (p.11)

“Overall performance met predefined specification limits, including ≤5 mm positional accuracy and ≤10° trajectory/orientation accuracy.”

time_to_resultas written: “algorithm latency”stated without value

source quote (p.11)

“Algorithm latency met predefined specification, including detection and localization of the therapy device within 100ms of reception of the echo image.”

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

recalls in product code, 24mo

MAUDE reports in code, 12mo

—

vs code's own 3-yr baseline

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).