Cleared Traditional

K864980 - 3MHZ ANNULAR ARRAY

K864980 is an FDA 510(k) clearance for 3MHZ ANNULAR ARRAY, manufactured by Philips Ultrasound, Inc.. The device is a Class 2 Cardiovascular device with product code JOP cleared through the Traditional 510(k) pathway after a 140-day FDA review.

K864980 · Philips Ultrasound, Inc. · Cardiovascular device
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May 1987
Decision
140d
Days
Class 2
Risk

K864980 is an FDA 510(k) clearance for the 3MHZ ANNULAR ARRAY. Classified as Transducer, Ultrasonic (product code JOP), Class II - Special Controls.

Submitted by Philips Ultrasound, Inc. (Santa Ana, US). The FDA issued a Cleared decision on May 11, 1987 after a review of 140 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 Philips Ultrasound, Inc. devices

FDA 510(k) Submission Details - K864980

510(k) Number K864980 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 22, 1986
Decision Date May 11, 1987
Days to Decision 140 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
15d slower than avg
Panel avg: 125d · This submission: 140d
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 K864980.
ACUSON L538 TRANSDUCER
K871506 · 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
ACUSON L558 TRANSDUCER
K861579 · Acuson Computed Sonography · Jul 1986
ACUSON S519 TRANSDUCER
K861596 · Acuson Computed Sonography · Jul 1986
MERIDIAN IMAGING SYSTEM
K861737 · Johnson & Johnson Professionals, Inc. · Jul 1986