Cleared Traditional

K910212 - COLOR DOPPLER OPTION TO AI 5200 DIAG ULTRASO SYST

K910212 is an FDA 510(k) clearance for COLOR DOPPLER OPTION TO AI 5200 DIAG UL..., manufactured by Acoustic Imaging Technologies Corp.. The device is a Class 1 Radiology device with product code JYO cleared through the Traditional 510(k) pathway after a 177-day FDA review.

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

FDA 510(k) Submission Details - K910212

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.

JYO Device Classification - Class 1, General Controls

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.