Cleared Traditional

K861578 - ACUSON S328, L382, L538 & L312 TRANSDUCERS (FDA 510(k) Clearance)

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

K861578 · Acuson Computed Sonography · Obstetrics & Gynecology device
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Jun 1986
Decision
50d
Days
Class 2
Risk

K861578 is an FDA 510(k) clearance for the ACUSON S328, L382, L538 & L312 TRANSDUCERS. Classified as Transducer, Ultrasonic, Obstetric (product code HGL), Class II - Special Controls.

Submitted by Acuson Computed Sonography (Mountain View, US). The FDA issued a Cleared decision on June 17, 1986 after a review of 50 days - a notably fast clearance cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.2960 - the FDA obstetrics and gynecology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Acuson Computed Sonography devices

Submission Details

510(k) Number K861578 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 28, 1986
Decision Date June 17, 1986
Days to Decision 50 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
110d faster than avg
Panel avg: 160d · This submission: 50d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HGL Transducer, Ultrasonic, Obstetric
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.2960
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 Obstetrics & Gynecology devices follow this clearance model.