BriefCase-Quantification
K242203Aidoc Medical, Ltd. · cleared 2024-11-22 · product code QIH · Radiology
Premarket evidence — what FDA accepted
source quote (p.5)
“BriefCase-Quantification is a radiological medical image management and processing device. The software consists of a single module based on an algorithm programmed component and is intended to run on a linux-based server in a cloud environment.”
source quote (p.6)
“All devices are artificial intelligence, deep-learning algorithms incorporating software packages for use with compliant scanners, PACS, and radiology workstations.”
source quote (p.10)
“The cases collected for the pivotal dataset were all distinct in time and/or center from the cases used to train the algorithm.”
Validation studies (1)
Retrospective clinical
n=212 cases · 6 site(s)
endpoints: evaluate the software's performance in providing quantitative diameter measurements across a set of 10 aorta landmarks and measurements of the maximum aortic diameter at three segments abdominal ascending, and descending
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. 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).