Cleared Traditional

K911384 - CATHSCANNER(R) VISIONS(TM) 3.5F 54700/5.0F 54600

K911384 is an FDA 510(k) clearance for CATHSCANNER VISIONS(TM) 3.5F 54700/5.0F..., manufactured by Endosonics Corp.. The device is a Class 2 Cardiovascular device with product code DXK cleared through the Traditional 510(k) pathway after a 89-day FDA review.

K911384 · Endosonics Corp. · Cardiovascular device
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Jun 1991
Decision
89d
Days
Class 2
Risk

K911384 is an FDA 510(k) clearance for the CATHSCANNER(R) VISIONS(TM) 3.5F 54700/5.0F 54600. Classified as Echocardiograph (product code DXK), Class II - Special Controls.

Submitted by Endosonics Corp. (Rancho Cordova, US). The FDA issued a Cleared decision on June 25, 1991 after a review of 89 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.

FDA 510(k) Submission Details - K911384

510(k) Number K911384 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 28, 1991
Decision Date June 25, 1991
Days to Decision 89 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
36d faster than avg
Panel avg: 125d · This submission: 89d
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 59
Devices cleared under the same product code (DXK) and FDA review panel - the closest regulatory comparables to K911384.
IN-VISION IMAGING SYSTEM
K031148 · Jomed, Inc. · May 2003
9750 ATHENA ETHERNET OPTION
K934887 · S & W Medico Teknik A/S · Jan 1994
ACCESSORY TO GENESIS III (GCFM)
K913209 · Biosound, Inc. · May 1992
MODIFIED SYST: SONOS 500/1000 ULTRSOUND IMAG SYST
K904832 · Hewlett-Packard Co. · Apr 1991
VISTA VIEWING STATION
K904975 · Prism Imaging, Inc. · Feb 1991
CINE'VIEW - STRESS ECHO & IMAGE REVIEW
K904976 · Prism Imaging, Inc. · Feb 1991
K911384 · CATHSCANNER(R) VISIONS(TM) 3.5F 54700/5.0F 54600
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