Cleared Traditional

K871555 - RT5000 W/QUANTI. SPEC. DOPPLER, CW DOPP. MODIFICA.

K871555 is an FDA 510(k) clearance for RT5000 W/QUANTI. SPEC. DOPPLER, manufactured by General Electric Co.. The device is a Class 2 Cardiovascular device with product code DXK cleared through the Traditional 510(k) pathway after a 315-day FDA review.

K871555 · General Electric Co. · Cardiovascular device
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Mar 1988
Decision
315d
Days
Class 2
Risk

K871555 is an FDA 510(k) clearance for the RT5000 W/QUANTI. SPEC. DOPPLER, CW DOPP. MODIFICA.. Classified as Echocardiograph (product code DXK), Class II - Special Controls.

Submitted by General Electric Co. (Milwaukee, US). The FDA issued a Cleared decision on March 2, 1988 after a review of 315 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 General Electric Co. devices

FDA 510(k) Submission Details - K871555

510(k) Number K871555 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 22, 1987
Decision Date March 02, 1988
Days to Decision 315 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
190d slower than avg
Panel avg: 125d · This submission: 315d
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 K871555.
CATHSCANNER INTRAVASCULAR ULTRASONIC IMAGING SYST.
K883888 · Advanced Biosearch Assn. · Dec 1988
SSD-870 CARDIO VASCULAR PHASED ARRAY SECTOR SCANN.
K880217 · Ge Medical Systems Information Technologies · Apr 1988
EUB-305 DIAGNOSTIC ULTRASOUND DEVICE
K870878 · Hitachi Medical Corp. of America · Apr 1988
GENESIS II, 2.5/5.0 MHZ S.E/5.0MHZ/3.5 16/19 MM AN
K873032 · Biosound, Inc. · Feb 1988
SERIES 77000 ULTRASOUND IMAGING SYSTEM
K873762 · Hewlett-Packard Co. · Feb 1988
GENESIS II
K871697 · Biosound, Inc. · Nov 1987