Cleared Traditional

K861578 - ACUSON S328

K861578 is an FDA 510(k) clearance for ACUSON S328, manufactured by Acuson Computed Sonography. The device is a Class 2 Obstetrics & Gynecology device with product code HGL cleared through the Traditional 510(k) pathway after a 50-day FDA review.

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

FDA 510(k) Submission Details - K861578

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
Combination Product No
PCCP Authorized No
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.

HGL Device Classification - Class 2, Special Controls

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.

Regulatory Peers - HGL Transducer, Ultrasonic, Obstetric

All 21
Devices cleared under the same product code (HGL) and FDA review panel - the closest regulatory comparables to K861578.
7.5 MHZ ENDOVAGINAL PROBE
K870709 · Philips Ultrasound, Inc. · Mar 1987
TRANSVAGINAL PROBE, MODEL ED65M-TV
K861371 · Elscint, Inc. · Jul 1986
ACUSON S228, S519 & L558 TRANSDUCERS
K861577 · Acuson Computed Sonography · Jun 1986
TRANSVAGINAL TRANSDUCER, 5MHZ
K860234 · Philips Medical Systems, Inc. · May 1986
3.0 MHZ LINEAR ARRAY PROBE MODEL UST 5031
K860313 · Johnson & Johnson Professionals, Inc. · Mar 1986
ARTIUS SYSTEM
K771151 · General Electric Co. · Aug 1977