Cleared Traditional

K871506 - ACUSON L538 TRANSDUCER

K871506 is an FDA 510(k) clearance for ACUSON L538 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 164-day FDA review.

K871506 · Acuson Computed Sonography · Cardiovascular device
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Sep 1987
Decision
164d
Days
Class 2
Risk

K871506 is an FDA 510(k) clearance for the ACUSON L538 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 September 28, 1987 after a review of 164 days - an extended review cycle.

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 - K871506

510(k) Number K871506 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 17, 1987
Decision Date September 28, 1987
Days to Decision 164 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
39d slower than avg
Panel avg: 125d · This submission: 164d
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 K871506.
BIOSOUND MMI ULTRASOUND
K871442 · Biosound, Inc. · May 1988
RT5000 ECHOCARDIOGRAPHY #H4100C/CE
K870726 · General Electric Co. · Oct 1987
AUXILIARY CONTINUOUS WAVE DOPPLER TRANSDUCER
K871416 · Acuson Computed Sonography · Sep 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
3MHZ ANNULAR ARRAY
K864980 · Philips Ultrasound, Inc. · May 1987