Cleared Traditional

K861538 - 860 COLOR DOPPLER OR COLORVIEW 860

K861538 is an FDA 510(k) clearance for 860 COLOR DOPPLER OR COLORVIEW 860, manufactured by Ge Medical Systems Information Technologies. The device is a Class 2 Radiology device with product code IYO cleared through the Traditional 510(k) pathway after a 123-day FDA review.

K861538 · Ge Medical Systems Information Technologies · Radiology device
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Aug 1986
Decision
123d
Days
Class 2
Risk

K861538 is an FDA 510(k) clearance for the 860 COLOR DOPPLER OR COLORVIEW 860. Classified as System, Imaging, Pulsed Echo, Ultrasonic (product code IYO), Class II - Special Controls.

Submitted by Ge Medical Systems Information Technologies (Ramsey, US). The FDA issued a Cleared decision on August 25, 1986 after a review of 123 days - within the typical 510(k) review window.

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. 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 Ge Medical Systems Information Technologies devices

FDA 510(k) Submission Details - K861538

510(k) Number K861538 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 24, 1986
Decision Date August 25, 1986
Days to Decision 123 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
16d slower than avg
Panel avg: 107d · This submission: 123d
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

All 449
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