3mensio Workstation

K250330

Pie 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 models for automatically determined segmentations and measurements
source quote (p.9)
“No datasets were included that were used for training the machine learning models. Performance testing was conducted where the results of automatically determined segmentation and measurements was evaluated against ground-truth values manually obtained by experts with the primary predicate device.”
Adaptive (vs locked)No
source quote (p.9)
“No datasets were included that were used for training the machine learning models.”
PCCPNo
Cybersecurity addressedYes
source quote (p.8)
“Any risks related to information security (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 (Dice scores); accuracy of automatically determined measurements (Bland-Altman analysis, intraclass correlation coefficient)

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 measurements)”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”
agreement_kappaas written: “ICC (mitral annulus measurements)”0.94CI and above
source quote (p.9)
“0.94 and above for the measurements on the mitral annulus”
agreement_kappaas written: “ICC (tricuspid annulus measurements)”0.97CI and above
source quote (p.9)
“0.97 and above for the measurements on the tricuspid annulus”

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); a recall is shown as device-attributed only when the recall record itself lists this clearance number. 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).

Applicable FDA guidance — what the submission is measured against

FDA guidance documents and guiding principles applicable to 510(k) AI/ML devices in the Radiology panel. A curated reference index, not legal or regulatory advice — each item states its own status, and a draft is never binding.

Applicability is derived from the device's FDA advisory panel and pathway — cross-cutting guidances apply to every AI/ML device; panel-specific ones are flagged. Titles, dates, and links verified against fda.gov as of July 2026.

Constat Precedent · public FDA/CMS data · descriptive decision-support, not regulatory or reimbursement advice. Share this page: constat.dev/precedent/device/K250330