Cleared Traditional

K890055 - ACUSON S228 TRANSDUCER FOR TRANSCRANIAL...

K890055 is the FDA 510(k) clearance for ACUSON S228 TRANSDUCER FOR TRANSCRANIAL... by Acuson Corp.. It is a Class 2 Radiology device (product code IYN) cleared through the Traditional 510(k) pathway after a 130-day FDA review.

K890055 · Acuson Corp. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1989
Decision
130d
Days
Class 2
Risk

K890055 is an FDA 510(k) clearance for the ACUSON S228 TRANSDUCER FOR TRANSCRANIAL DOPPLER. Classified as System, Imaging, Pulsed Doppler, Ultrasonic within the IYN classification (a category covering pulsed Doppler and ultrasound imaging systems), Class II - Special Controls.

Submitted by Acuson Corp. (Mountain View, US). The FDA issued a Cleared decision on May 16, 1989 after a review of 130 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1550 - 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 K890055 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 06, 1989
Decision Date May 16, 1989
Days to Decision 130 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
23d slower than avg
Panel avg: 107d · This submission: 130d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code IYN System, Imaging, Pulsed Doppler, Ultrasonic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1550
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 - IYN System, Imaging, Pulsed Doppler, Ultrasonic

All 793
Devices cleared under the same product code (IYN) and FDA review panel - the closest regulatory comparables to K890055.
CEPHALIC DOPPLER W/ULTRAMARK 9 ULTRASOUND SYSTEM
K901329 · Advanced Technology Laboratories, Inc. · Nov 1990
5.0 MHZ ARRAY INTRAVAGINAL TRANSDUCER
K894054 · Advanced Technology Laboratories, Inc. · Sep 1989
PHASE 2 TRANSCRANIAL PROBE
K894163 · Biosound, Inc. · Sep 1989
CAVROLAB
K882585 · Life-Tech Intl., Inc. · Mar 1989
ACUSON I7505 TRANSDUCER, ULTRASOUND TRANSDUCER
K882737 · Acuson Corp. · Sep 1988
5 MHZ DOPPLER OUTRIGGER
K872817 · Philips Ultrasound, Inc. · Feb 1988