Cleared Traditional

K904951 - S5192R TRANSDUCER (FDA 510(k) Clearance)

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K904951 · Acuson Corp. · Radiology device
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Apr 1991
Decision
178d
Days
Class 2
Risk

K904951 is an FDA 510(k) clearance for the S5192R TRANSDUCER. Classified as Monitor, Fetal Doppler Ultrasound (product code MAA), Class II - Special Controls.

Submitted by Acuson Corp. (Mountain View, US). The FDA issued a Cleared decision on April 29, 1991 after a review of 178 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 884.2660 - 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 Acuson Corp. devices

Submission Details

510(k) Number K904951 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 02, 1990
Decision Date April 29, 1991
Days to Decision 178 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
71d slower than avg
Panel avg: 107d · This submission: 178d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MAA Monitor, Fetal Doppler Ultrasound
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.2660
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.