X9 Ultrasound System
K251673X9, Inc. · cleared 2025-10-17 · product code SGH · Radiology
Premarket evidence — what FDA accepted
Device typehardware with ml
source quote (p.5)
“The X9 Ultrasound System consists of a Handpiece and Software. The Handpiece is a handheld device with an ultrasound transducer and is attached via a cable to a user-supplied Computer. The software, which runs on a standard operating system platform installed on the Computer, provides the Graphical User Interface (GUI). The GUI will indicate when the Handpiece is aligned with the AVF/G. A Machine Learning Model Validation was performed to confirm that the ML model correctly determined if an access vessel was visible and if the average lateral error between the ML Model and the access vessel True Location was acceptable.”
AlgorithmMachine Learning Model
source quote (p.7)
“A Machine Learning Model Validation was performed to confirm that the ML model correctly determined if an access vessel was visible and if the average lateral error between the ML Model and the access vessel True Location was acceptable.”
Adaptive (vs locked)FDA source did not state this
PCCPFDA source did not state this
Cybersecurity addressedYes
source quote (p.7)
“Cybersecurity Testing”
Validation studies (1)
Retrospective clinical
n=63 patients
endpoints: Access Presence Sensitivity; average lateral error between the ML Model and the access vessel True Location; Dice Similarity Coefficient (DSC)
Reported performance (2 observations)
sensitivity94.5
source quote (p.8)
“The calculated Access Presence Sensitivity was 94.5%, which exceeded the acceptance criteria of greater than or equal to 75%.”
diceas written: “Dice Similarity Coefficient (DSC)”81.3
source quote (p.8)
“The average Dice Similarity Coefficient (DSC) across all reviewers was 81.3%, which meets the acceptance criterion of 75% minimum.”
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
0
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).