Cleared Traditional

K901658 - ADD'L TRANSDUCER FOR USE W/EUB-165 ULTRASOUND

K901658 is an FDA 510(k) clearance for ADD'L TRANSDUCER FOR USE W/EUB-165 ULTR..., manufactured by Hitachi Medical Corp. of America. The device is a Class 2 Cardiovascular device with product code DXK cleared through the Traditional 510(k) pathway after a 147-day FDA review.

K901658 · Hitachi Medical Corp. of America · Cardiovascular device
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Sep 1990
Decision
147d
Days
Class 2
Risk

K901658 is an FDA 510(k) clearance for the ADD'L TRANSDUCER FOR USE W/EUB-165 ULTRASOUND. Classified as Echocardiograph (product code DXK), Class II - Special Controls.

Submitted by Hitachi Medical Corp. of America (Tarrytown, US). The FDA issued a Cleared decision on September 4, 1990 after a review of 147 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 Hitachi Medical Corp. of America devices

FDA 510(k) Submission Details - K901658

510(k) Number K901658 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 10, 1990
Decision Date September 04, 1990
Days to Decision 147 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
22d slower than avg
Panel avg: 125d · This submission: 147d
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 K901658.
INTERSPEC APOGEE
K903839 · Interspec, Inc. · Nov 1990
MODEL MD-5 DOPPLER
K901592 · D. E. Hokanson, Inc. · Oct 1990
ADD'L TRANSDUCER FOR USE W/EUB-565 ULTRASOUND
K901657 · Hitachi Medical Corp. of America · Sep 1990
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