Cleared Traditional

K893042 - CATHSCANNER(R) INTRAVASCULAR ULTRA IMAGING SYSTEM

K893042 is an FDA 510(k) clearance for CATHSCANNER INTRAVASCULAR ULTRA IMAGING..., manufactured by Endosonics Corp.. The device is a Class 2 Radiology device with product code IYN cleared through the Traditional 510(k) pathway after a 86-day FDA review.

K893042 · Endosonics Corp. · Radiology device
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Jul 1989
Decision
86d
Days
Class 2
Risk

K893042 is an FDA 510(k) clearance for the CATHSCANNER(R) INTRAVASCULAR ULTRA IMAGING SYSTEM. Classified as System, Imaging, Pulsed Doppler, Ultrasonic within the IYN classification (a category covering pulsed Doppler and ultrasound imaging systems), Class II - Special Controls.

Submitted by Endosonics Corp. (Rancho Cordova, US). The FDA issued a Cleared decision on July 19, 1989 after a review of 86 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1550 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Endosonics Corp. devices

FDA 510(k) Submission Details - K893042

510(k) Number K893042 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 24, 1989
Decision Date July 19, 1989
Days to Decision 86 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
21d faster than avg
Panel avg: 107d · This submission: 86d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IYN Device Classification - Class 2, Special Controls

Product Code IYN System, Imaging, Pulsed Doppler, Ultrasonic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1550
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 - IYN System, Imaging, Pulsed Doppler, Ultrasonic

All 959
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