AiORTA - Plan v2.0
K254207ViTAA Medical Solutions, Inc. · cleared 2026-03-30 · product code QIH · Radiology
Premarket evidence — what FDA accepted
Device typesamd
source quote (p.4)
“The AiORTA - Plan tool is an image analysis software tool for volumetric assessment, image analysis, geometric analysis, and pre-operative sizing and planning. It provides volumetric visualization and measurements based on 3D reconstruction computed from cardiovascular CTA scans. The software device is intended to provide adjunct information to a licensed healthcare practitioner (HCP) in addition to clinical data and other inputs, as a measurement tool used in assessment of aortic aneurysm, pre-operative evaluation, planning and sizing for cardiovascular intervention and surgery, and for post-operative evaluation in patients 22 years old and older. The device is not intended to provide stand-alone diagnosis or suggest an immediate course of action in treatment or patient management”
AlgorithmAI-powered auto-masking algorithm
source quote (p.7)
“Segmentation: an Al-powered auto-masking algorithm performs segmentation of the aortic lumen, wall, and key anatomical landmarks, including the superior mesenteric, celiac, and renal arteries, as well as the external iliac arteries and a large portion of the descending aorta.”
Adaptive (vs locked)FDA source did not state this
PCCPFDA source did not state this
Cybersecurity addressedFDA source did not state this
Validation studies (0)
FDA source did not describe a validation study.
Reported performance (0 observations)
FDA source did not state a quantitative performance metric — non-reporting is itself the signal.
Each value carries its own analysis unit and task — never compare or pool across devices.
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).