Cleared Traditional

K874363 - ACUSON S228 AND S328 TRANSDUCERS FOR AB...

K874363 is an FDA 510(k) clearance for ACUSON S228 AND S328 TRANSDUCERS FOR AB..., manufactured by Acuson Computed Sonography. The device is a Class 2 Radiology device with product code IYO cleared through the Traditional 510(k) pathway after a 192-day FDA review.

K874363 · Acuson Computed Sonography · Radiology device
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May 1988
Decision
192d
Days
Class 2
Risk

K874363 is an FDA 510(k) clearance for the ACUSON S228 AND S328 TRANSDUCERS FOR ABDOM. APPLI.. Classified as System, Imaging, Pulsed Echo, Ultrasonic (product code IYO), Class II - Special Controls.

Submitted by Acuson Computed Sonography (Mountain View, US). The FDA issued a Cleared decision on May 2, 1988 after a review of 192 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1560 - 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 Computed Sonography devices

FDA 510(k) Submission Details - K874363

510(k) Number K874363 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 23, 1987
Decision Date May 02, 1988
Days to Decision 192 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
85d slower than avg
Panel avg: 107d · This submission: 192d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IYO Device Classification - Class 2, Special Controls

Product Code IYO System, Imaging, Pulsed Echo, Ultrasonic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1560
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.

Regulatory Peers - IYO System, Imaging, Pulsed Echo, Ultrasonic

All 449
Devices cleared under the same product code (IYO) and FDA review panel - the closest regulatory comparables to K874363.
EUB-450 DIAGNOSTIC ULTRASOUND DEVICE
K874211 · Hitachi Medical Corp. of America · Jun 1988
ACUSON S328 TRANSDUCER
K874028 · Acuson Computed Sonography · Jun 1988
ARTIS 3200 DIAGNOSTIC ULTRASOUND DEVICE
K875251 · Philips Medical Systems (Cleveland), Inc. · May 1988
7.5 MHZ ENDORECTAL PROBE
K881028 · Philips Ultrasound, Inc. · Apr 1988
DIASONICS QT ENDORECTAL 7.5 MHZ PROBE
K880714 · Diasonics, Inc. · Apr 1988
THE ESI-2000 ULTRASOUND UNIT
K874683 · Elscint, Inc. · Apr 1988