Cleared Traditional

K924079 - CFM-800 COLOR FLOW MAPPING SYSTEM

K924079 is an FDA 510(k) clearance for CFM-800 COLOR FLOW MAPPING SYSTEM, manufactured by Diasonics, Inc.. The device is a Class 2 Radiology device with product code IYO cleared through the Traditional 510(k) pathway after a 411-day FDA review.

K924079 · Diasonics, Inc. · Radiology device
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Sep 1993
Decision
411d
Days
Class 2
Risk

K924079 is an FDA 510(k) clearance for the CFM-800 COLOR FLOW MAPPING SYSTEM. Classified as System, Imaging, Pulsed Echo, Ultrasonic (product code IYO), Class II - Special Controls.

Submitted by Diasonics, Inc. (Milipitas, US). The FDA issued a Cleared decision on September 28, 1993 after a review of 411 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Radiology submissions.

View all Diasonics, Inc. devices

FDA 510(k) Submission Details - K924079

510(k) Number K924079 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 13, 1992
Decision Date September 28, 1993
Days to Decision 411 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
304d slower than avg
Panel avg: 107d · This submission: 411d
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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