Cleared Traditional

K926351 - COLORMARK(TM) VISUALIZATION SYSTEM

K926351 is an FDA 510(k) clearance for COLORMARK(TM) VISUALIZATION SYSTEM, manufactured by Echocath, Inc.. The device is a Class 2 Radiology device with product code IYN cleared through the Traditional 510(k) pathway after a 273-day FDA review.

K926351 · Echocath, Inc. · Radiology device
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Optimized for regulatory review, auditing and printing
Sep 1993
Decision
273d
Days
Class 2
Risk

K926351 is an FDA 510(k) clearance for the COLORMARK(TM) VISUALIZATION 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 Echocath, Inc. (Princeton, US). The FDA issued a Cleared decision on September 16, 1993 after a review of 273 days - an extended review 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: 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 Echocath, Inc. devices

FDA 510(k) Submission Details - K926351

510(k) Number K926351 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 17, 1992
Decision Date September 16, 1993
Days to Decision 273 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
166d slower than avg
Panel avg: 107d · This submission: 273d
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 964
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