Cleared Traditional

K232156 - Rapid ASPECTS (v3) (FDA 510(k) Clearance)

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K232156 · Ischemaview, Inc. · Radiology device
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Jan 2024
Decision
183d
Days
Class 2
Risk

K232156 is an FDA 510(k) clearance for the Rapid ASPECTS (v3). Classified as Computer-assisted Diagnostic Software For Lesions Suspicious For Cancer (product code POK), Class II - Special Controls.

Submitted by Ischemaview, Inc. (Golden, US). The FDA issued a Cleared decision on January 19, 2024 after a review of 183 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.2060 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Ischemaview, Inc. devices

Submission Details

510(k) Number K232156 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 20, 2023
Decision Date January 19, 2024
Days to Decision 183 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
76d slower than avg
Panel avg: 107d · This submission: 183d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code POK Computer-assisted Diagnostic Software For Lesions Suspicious For Cancer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.2060
Definition Assist Users In Characterizing Lesions Identified On Acquired Medical Images
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 - POK Computer-assisted Diagnostic Software For Lesions Suspicious For Cancer

All 20
Devices cleared under the same product code (POK) and FDA review panel - the closest regulatory comparables to K232156.
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