Cleared Traditional

K910212 - COLOR DOPPLER OPTION TO AI 5200 DIAG ULTRASO SYST (FDA 510(k) Clearance)

Class I Radiology device.

K910212 · Acoustic Imaging Technologies Corp. · Radiology device
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Jul 1991
Decision
177d
Days
Class 1
Risk

K910212 is an FDA 510(k) clearance for the COLOR DOPPLER OPTION TO AI 5200 DIAG ULTRASO SYST. Classified as Knife, Ear (product code JYO), Class I - General Controls.

Submitted by Acoustic Imaging Technologies Corp. (Phoenix, US). The FDA issued a Cleared decision on July 11, 1991 after a review of 177 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 874.4420 - 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: Incremental AI imaging tool. Moderate equivalence dependency. Overall, this clearance reflects a predicate-aligned approval typical of modern AI radiology extensions - not a novel clinical breakthrough, but a validated iteration within an established regulatory category.

View all Acoustic Imaging Technologies Corp. devices

Submission Details

510(k) Number K910212 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 15, 1991
Decision Date July 11, 1991
Days to Decision 177 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
70d slower than avg
Panel avg: 107d · This submission: 177d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JYO Knife, Ear
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 874.4420
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.