Cleared Traditional

K220499 - Rapid PE Triage and Notification (PETN)

K220499 is the FDA 510(k) clearance for Rapid PE Triage and Notification (PETN) by Ischemaview, Inc.. It is a Class 2 Radiology device (product code QAS) cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K220499 · Ischemaview, Inc. · Radiology device
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May 2022
Decision
84d
Days
Class 2
Risk

K220499 is an FDA 510(k) clearance for the Rapid PE Triage and Notification (PETN). Classified as Radiological Computer-assisted Triage And Notification Software (product code QAS), Class II - Special Controls.

Submitted by Ischemaview, Inc. (Golden, US). The FDA issued a Cleared decision on May 17, 2022 after a review of 84 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.2080 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Incremental AI imaging tool. Moderate equivalence dependency. Overall, this clearance reflects a predicate-aligned approval typical of modern AI radiology extensions - not a novel clinical breakthrough, but a validated iteration within an established regulatory category.

View all Ischemaview, Inc. devices

Submission Details

510(k) Number K220499 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 22, 2022
Decision Date May 17, 2022
Days to Decision 84 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
23d faster than avg
Panel avg: 107d · This submission: 84d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code QAS Radiological Computer-assisted Triage And Notification Software
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.2080
Definition Radiological Computer-assisted Triage And Notification Software Is An Image Processing Device Intended To Aid In Prioritization And Triage Of Time Sensitive Patient Detection And Diagnosis Based On The Analysis Of Medical Images Acquired From Radiological Signal Acquisition Systems. The Device Identifies Or Prioritizes Time Sensitive Imaging For Review By Prespecified Clinical Users Based On Software-based Image Analysis But Does Not Provide Information From The Image Analysis Other Than Triage And Notification .
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - QAS Radiological Computer-assisted Triage And Notification Software

All 84
Devices cleared under the same product code (QAS) and FDA review panel - the closest regulatory comparables to K220499.
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K220439 · Viz. Ai, Inc. · Jul 2022
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K221314 · Aidoc Medical , Ltd. · Jun 2022
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K221248 · Ischemaview, Inc. · May 2022
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K221240 · Aidoc Medical , Ltd. · May 2022
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