Cleared Traditional

K896543 - ULTRAMARK 7 ULTRASOUND SYSTEM

K896543 is an FDA 510(k) clearance for ULTRAMARK 7 ULTRASOUND SYSTEM, manufactured by Advanced Technology Laboratories, Inc.. The device is a Class 2 Cardiovascular device with product code DXK cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K896543 · Advanced Technology Laboratories, Inc. · Cardiovascular device
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Feb 1990
Decision
90d
Days
Class 2
Risk

K896543 is an FDA 510(k) clearance for the ULTRAMARK 7 ULTRASOUND SYSTEM. Classified as Echocardiograph (product code DXK), Class II - Special Controls.

Submitted by Advanced Technology Laboratories, Inc. (Bothell, US). The FDA issued a Cleared decision on February 15, 1990 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2330 - 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 Advanced Technology Laboratories, Inc. devices

FDA 510(k) Submission Details - K896543

510(k) Number K896543 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 17, 1989
Decision Date February 15, 1990
Days to Decision 90 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
35d faster than avg
Panel avg: 125d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DXK Device Classification - Class 2, Special Controls

Product Code DXK Echocardiograph
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2330
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 - DXK Echocardiograph

All 46
Devices cleared under the same product code (DXK) and FDA review panel - the closest regulatory comparables to K896543.
CVIS INSIGHT IMAGING CATHETER
K901562 · Cardiovascular Imaging Systems, Inc. · Jul 1990
DOPPLER OPTION FOR PLATINUM
K900002 · Philips Medical Systems North America, Inc. · Apr 1990
EUB-165
K895326 · Hitachi Medical Corp. of America · Mar 1990
GENESIS III, (MOD. 7003/7004)
K894370 · Biosound, Inc. · Jan 1990
MODEL SSH-140A ULTRASOUND IMAGING SYSTEM
K894632 · Toshiba America Medical Systems, In.C · Oct 1989
CATHSCANNER INTRAVASCULAR ULTRASONIC IMAGING SYST.
K883888 · Advanced Biosearch Assn. · Dec 1988