Cleared Traditional

K861596 - ACUSON S519 TRANSDUCER

K861596 is an FDA 510(k) clearance for ACUSON S519 TRANSDUCER, manufactured by Acuson Computed Sonography. The device is a Class 2 Cardiovascular device with product code JOP cleared through the Traditional 510(k) pathway after a 92-day FDA review.

K861596 · Acuson Computed Sonography · Cardiovascular device
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Jul 1986
Decision
92d
Days
Class 2
Risk

K861596 is an FDA 510(k) clearance for the ACUSON S519 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 92 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

FDA 510(k) Submission Details - K861596

510(k) Number K861596 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received April 29, 1986
Decision Date July 30, 1986
Days to Decision 92 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
33d faster than avg
Panel avg: 125d · This submission: 92d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JOP Device Classification - Class 2, Special Controls

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 36
Devices cleared under the same product code (JOP) and FDA review panel - the closest regulatory comparables to K861596.
SSD-633 PHASED ARRAY SECTOR/LINEAR ULTRASOUND SYS.
K870916 · Ge Medical Systems Information Technologies · Jul 1987
3MHZ ANNULAR ARRAY
K864980 · Philips Ultrasound, Inc. · May 1987
ACUSON L558 TRANSDUCER
K861579 · Acuson Computed Sonography · Jul 1986
MERIDIAN IMAGING SYSTEM
K861737 · Johnson & Johnson Professionals, Inc. · Jul 1986
ACUSON S319 TRANSDUCER
K862159 · Acuson Computed Sonography · Jul 1986
ACUSON L382 AND L312 TRANSDUCERS
K861866 · Acuson Computed Sonography · Jul 1986