Cleared Traditional

K200760 - Rapid ASPECTS

K200760 is an FDA 510(k) clearance for Rapid ASPECTS, manufactured by Ischemaview, Inc.. The device is a Class 2 Radiology device with product code POK cleared through the Traditional 510(k) pathway after a 94-day FDA review.

K200760 · Ischemaview, Inc. · Radiology device
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Jun 2020
Decision
94d
Days
Class 2
Risk

K200760 is an FDA 510(k) clearance for the Rapid ASPECTS. 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 June 26, 2020 after a review of 94 days - within the typical 510(k) review window.

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

FDA 510(k) Submission Details - K200760

510(k) Number K200760 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 24, 2020
Decision Date June 26, 2020
Days to Decision 94 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
13d faster than avg
Panel avg: 107d · This submission: 94d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

POK Device Classification - Class 2, Special Controls

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 22
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