Rapid PE Triage and Notification (PETN)
K220499iSchemaView Inc. · cleared 2022-05-17 · product code QAS · Radiology
Premarket evidence — what FDA accepted
source quote (p.3)
“Rapid PE Triage and Notification (PETN) is a radiological computer aided triage and notification software indicated for use in the analysis of CTPA images.”
source quote (p.3)
“Rapid PETN uses an artificial intelligence algorithm to analyze images and highlight cases with detected findings on a server or standalone desktop application in parallel to the ongoing standard of care image interpretation. The PETN module is an AI/ML module.”
Validation studies (2)
Retrospective clinical
n=600 cases
Standalone
n=306 cases
endpoints: Sensitivity; Specificity; processing time
standards: EN ISO 14971:2019, IEC 62304:2016, IEC 62366:2015, NEMA PS 3.1 - 3.20
Reported performance (2 observations)
source quote (p.8)
“The primary endpoint passed with Sensitivity = 0.96 (0.92,0.98) and Specificity = 0.89 (0.83,0.93).”
source quote (p.8)
“The primary endpoint passed with Sensitivity = 0.96 (0.92,0.98) and Specificity = 0.89 (0.83,0.93).”
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
- re_clearance
The FDA AI/ML device list shows a newer 510(k) K233512 (decision 2024-01-16) from iSchemaView, Inc. for a matching device line ("Rapid (6.0)") — a new clearance for the same line is a change event.
first seen 2026-07-08 · k_number:K233512
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).