Cleared Traditional

K864278 - DS-II DIGITAL SONOGRAPHY SYSTEM

K864278 is an FDA 510(k) clearance for DS-II DIGITAL SONOGRAPHY SYSTEM, manufactured by Intl. Acoustics, Inc.. The device is a Class 2 Cardiovascular device with product code DQD cleared through the Traditional 510(k) pathway after a 223-day FDA review.

K864278 · Intl. Acoustics, Inc. · Cardiovascular device
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Jun 1987
Decision
223d
Days
Class 2
Risk

K864278 is an FDA 510(k) clearance for the DS-II DIGITAL SONOGRAPHY SYSTEM. Classified as Stethoscope, Electronic (product code DQD), Class II - Special Controls.

Submitted by Intl. Acoustics, Inc. (Palatine, US). The FDA issued a Cleared decision on June 10, 1987 after a review of 223 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1875 - 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 Intl. Acoustics, Inc. devices

FDA 510(k) Submission Details - K864278

510(k) Number K864278 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 30, 1986
Decision Date June 10, 1987
Days to Decision 223 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
98d slower than avg
Panel avg: 125d · This submission: 223d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DQD Device Classification - Class 2, Special Controls

Product Code DQD Stethoscope, Electronic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1875
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 - DQD Stethoscope, Electronic

All 115
Devices cleared under the same product code (DQD) and FDA review panel - the closest regulatory comparables to K864278.
E-SCOPE ELECTRONIC STETHOSCOPE MODEL 718-7120
K961301 · Delphi Consulting Group · Jun 1996
3M LITTMANN GRAPHIC DISPLAY SYSTEM
K920009 · 3M Health Care, Ltd. · Oct 1992
MASCOT STETHOSCOPE PROBE
K874726 · Imex Medical Systems, Inc. · Mar 1988
DIF-STET
K832882 · Intersect Systems, Inc. · Dec 1983
CONPHAR SUPERTONE STETHOSCOPE
K801189 · Conphar, Inc. · Jun 1980
CONPHAR STETHSCOPE
K792112 · Conphar, Inc. · Dec 1979