Cleared Traditional

K792540 - SONACOLOR 6000

K792540 is an FDA 510(k) clearance for SONACOLOR 6000, manufactured by Carolina Medical Electronics. The device is a Class 2 Cardiovascular device with product code DXK cleared through the Traditional 510(k) pathway after a 38-day FDA review.

K792540 · Carolina Medical Electronics · Cardiovascular device
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Jan 1980
Decision
38d
Days
Class 2
Risk

K792540 is an FDA 510(k) clearance for the SONACOLOR 6000. Classified as Echocardiograph (product code DXK), Class II - Special Controls.

Submitted by Carolina Medical Electronics (Mchenry, US). The FDA issued a Cleared decision on January 17, 1980 after a review of 38 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Carolina Medical Electronics devices

FDA 510(k) Submission Details - K792540

510(k) Number K792540 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 10, 1979
Decision Date January 17, 1980
Days to Decision 38 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
87d faster than avg
Panel avg: 125d · This submission: 38d
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 47
Devices cleared under the same product code (DXK) and FDA review panel - the closest regulatory comparables to K792540.
ULTRA IMAGER
K800553 · Honeywell, Inc. · Jul 1980
LINEAR ARRAY SCANNER
K800805 · Philips Medical Systems (Cleveland), Inc. · Jul 1980
IPCO M-101 ECHOCARDIOGRAPH (IPCO ULTRA-
K792373 · Ipco Corp. · Feb 1980
CATHODE RAY TUBE DISPLAY MODEL 1340A
K780332 · Hewlett-Packard Co. · Mar 1978
HIGH-SPEED SECTOR SCANNING SSL-52H
K771292 · Toshiba Medical Systems · Aug 1977
ECHOCARDIOGRAPHY SYS., MODEL 3830
K770755 · Honeywell, Inc. · May 1977