3mensio Workstation
K250330Pie Medical Imaging BV · cleared 2025-11-03 · product code QIH · Radiology
Premarket evidence — what FDA accepted
Device typesamd
source quote (p.5)
“Standalone diagnostic bioimaging software is intended to measure and visualize cardiovascular structures.”
Algorithmmachine learning (ML) features
source quote (p.6)
“In addition, the 3mensio Workstation includes machine learning (ML) features for some of the functionalities already available in the primary predicate device.”
Adaptive (vs locked)FDA source did not state this
PCCPFDA source did not state this
Cybersecurity addressedYes
source quote (p.8)
“Any risks related to web-based availability (both on-premise and in the cloud) are mitigated by cybersecurity measures.”
Validation studies (1)
Retrospective clinical
n=65 patients
endpoints: accuracy of automatically determined segmentations; accuracy of automatically determined measurements
standards: ISO 13485, ISO 14971, IEC 62304, IEC 62366-1, IEC 82304-1
Reported performance (5 observations)
diceas written: “Dice score (mitral annulus)”0.94CI ± 0.07
source quote (p.9)
“The resulting Dice scores ranged from 0.94 ± 0.07 for the mitral annulus, 0.87 ± 0.12 for the tricuspid annulus.”
diceas written: “Dice score (tricuspid annulus)”0.87CI ± 0.12
source quote (p.9)
“The resulting Dice scores ranged from 0.94 ± 0.07 for the mitral annulus, 0.87 ± 0.12 for the tricuspid annulus.”
agreement_kappaas written: “ICC (aortic annulus plane)”0.99
source quote (p.9)
“The ICC values were 0.99 for the measurements on the aortic annulus plane derived from the aortic nadir positions, 0.94 and above for the measurements on the mitral annulus and 0.97 and above for the measurements on the tricuspid annulus indicating excellent agreement with the ground-truth values obtained by experts.”
agreement_kappaas written: “ICC (mitral annulus)”0.94CI and above
source quote (p.9)
“The ICC values were 0.99 for the measurements on the aortic annulus plane derived from the aortic nadir positions, 0.94 and above for the measurements on the mitral annulus and 0.97 and above for the measurements on the tricuspid annulus indicating excellent agreement with the ground-truth values obtained by experts.”
agreement_kappaas written: “ICC (tricuspid annulus)”0.97CI and above
source quote (p.9)
“The ICC values were 0.99 for the measurements on the aortic annulus plane derived from the aortic nadir positions, 0.94 and above for the measurements on the mitral annulus and 0.97 and above for the measurements on the tricuspid annulus indicating excellent agreement with the ground-truth values obtained by experts.”
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).