Rapid Aortic Measurements
K251987iSchemaView, Inc. · cleared 2025-09-23 · product code QIH · Radiology
Premarket evidence — what FDA accepted
source quote (p.5)
“Rapid Aortic Measurements (AM) is a Software as a Medical Device (SaMD) image processing module and is part of the Rapid Platform.”
source quote (p.8)
“AI/ML; traditional”
source quote (p.9)
“Rapid Aortic Measurements has been designed to meet the cybersecurity requirements using design Vulnerability Assessments, SBOM's, and PEN Testing.”
Validation studies (1)
Retrospective clinical
n=115 patients
endpoints: segmentation quality/clinical accuracy; CPR/MPR quality; anatomical labeling; maximum oblique diameter location accuracy; centerline accuracy; reproducibility of generating ground truths; mean absolute error (MAE)
standards: ISO 14971:2019, IEC 62304:2015, IEC 62366-1:2015 +A1:2020, NEMA PS 3.1 - 3.20, ISO 15223-1:2021, 21 CFR, Part 820.30
Reported performance (2 observations)
source quote (p.10)
“For VR outputs, the primary endpoint passed with an average Dice coefficient of 0.93 and average Hausdorff distance of 0.54 mm.”
source quote (p.10)
“The secondary endpoint, reproducibility of generating ground truths, showed an average Dice coefficient of 0.95, demonstrating strong reproducibility of ground truth segmentations.”
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
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).