Cleared Traditional

CATHSCANNER INTRAVASCULAR ULTRASONIC IMAGING SYST. (K883888) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K883888 · Advanced Biosearch Assn. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1988
Decision
88d
Days
Class 2
Risk

K883888 is an FDA 510(k) clearance for the CATHSCANNER INTRAVASCULAR ULTRASONIC IMAGING SYST.. Classified as Echocardiograph (product code DXK), Class II - Special Controls.

Submitted by Advanced Biosearch Assn. (Danville, US). The FDA issued a Cleared decision on December 12, 1988 after a review of 88 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 Advanced Biosearch Assn. devices

Submission Details

510(k) Number K883888 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 15, 1988
Decision Date December 12, 1988
Days to Decision 88 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
37d faster than avg
Panel avg: 125d · This submission: 88d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 14
Devices cleared under the same product code (DXK) and FDA review panel - the closest regulatory comparables to K883888.
Ultra ICE Plus 9 MHz IntraCardiac Echo Catheter(eDFU), Ultra ICE Plus 9 MHz IntraCardiac Echo Catheter (Paper DFU)
K160173 · Boston Scientific Corporation · Feb 2016
MODIFIED SYST: SONOS 500/1000 ULTRSOUND IMAG SYST
K904832 · Hewlett-Packard Co. · Apr 1991
MODEL SSH-140A ULTRASOUND IMAGING SYSTEM
K894632 · Toshiba America Medical Systems, In.C · Oct 1989
SSD-870 CARDIO VASCULAR PHASED ARRAY SECTOR SCANN.
K880217 · Ge Medical Systems Information Technologies · Apr 1988
RT5000 W/QUANTI. SPEC. DOPPLER, CW DOPP. MODIFICA.
K871555 · General Electric Co. · Mar 1988
SERIES 77000 ULTRASOUND IMAGING SYSTEM
K873762 · Hewlett-Packard Co. · Feb 1988