Cleared Traditional

ACUSON L558 TRANSDUCER (K861579) - FDA 510(k) Clearance

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

K861579 · Acuson Computed Sonography · Cardiovascular device
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Jul 1986
Decision
93d
Days
Class 2
Risk

K861579 is an FDA 510(k) clearance for the ACUSON L558 TRANSDUCER. Classified as Transducer, Ultrasonic (product code JOP), Class II - Special Controls.

Submitted by Acuson Computed Sonography (Mountain View, US). The FDA issued a Cleared decision on July 30, 1986 after a review of 93 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2880 - the FDA cardiovascular device 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 Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Acuson Computed Sonography devices

Submission Details

510(k) Number K861579 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received April 28, 1986
Decision Date July 30, 1986
Days to Decision 93 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
32d faster than avg
Panel avg: 125d · This submission: 93d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JOP Transducer, Ultrasonic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2880
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 Cardiovascular devices follow this clearance model.

Regulatory Peers - JOP Transducer, Ultrasonic

All 16
Devices cleared under the same product code (JOP) and FDA review panel - the closest regulatory comparables to K861579.
RT5000 ECHOCARDIOGRAPHY #H4100C/CE
K870726 · General Electric Co. · Oct 1987
SSD-725 ULTRASOUND SECTOR SCANNER
K870607 · Ge Medical Systems Information Technologies · Aug 1987
SSD-633 PHASED ARRAY SECTOR/LINEAR ULTRASOUND SYS.
K870916 · Ge Medical Systems Information Technologies · Jul 1987
MERIDIAN IMAGING SYSTEM
K861737 · Johnson & Johnson Professionals, Inc. · Jul 1986
ULTRASOUND TRANSDUCER #21230A 7.5MHZ SHORT FOCUS
K860652 · Hewlett-Packard Co. · May 1986
ULTRASONIC COUPLANT GEL
K854996 · Johnson & Johnson Professionals, Inc. · Apr 1986