Cleared Traditional

K926252 - CATHSCANNER II INTRAVASCULAR ULTRASONIC IMAGING SY

K926252 is an FDA 510(k) clearance for CATHSCANNER II INTRAVASCULAR ULTRASONIC..., manufactured by Endosonics Corp.. The device is a Class 2 Radiology device with product code IYO cleared through the Traditional 510(k) pathway after a 315-day FDA review.

K926252 · Endosonics Corp. · Radiology device
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Oct 1993
Decision
315d
Days
Class 2
Risk

K926252 is an FDA 510(k) clearance for the CATHSCANNER II INTRAVASCULAR ULTRASONIC IMAGING SY. Classified as System, Imaging, Pulsed Echo, Ultrasonic (product code IYO), Class II - Special Controls.

Submitted by Endosonics Corp. (Rancho Cordova, US). The FDA issued a Cleared decision on October 25, 1993 after a review of 315 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1560 - 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. Elevated predicate reliance profile. 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 Endosonics Corp. devices

FDA 510(k) Submission Details - K926252

510(k) Number K926252 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 14, 1992
Decision Date October 25, 1993
Days to Decision 315 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
208d slower than avg
Panel avg: 107d · This submission: 315d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IYO Device Classification - Class 2, Special Controls

Product Code IYO System, Imaging, Pulsed Echo, Ultrasonic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1560
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 - IYO System, Imaging, Pulsed Echo, Ultrasonic

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