Cleared Special

K051679 - ILAB ULTRASOUND IMAGING SYSTEM

K051679 is the FDA 510(k) clearance for ILAB ULTRASOUND IMAGING SYSTEM by Boston Scientific Corp. It is a Class 2 Cardiovascular device (product code OBJ) cleared through the Special 510(k) pathway after a 21-day FDA review.

K051679 · Boston Scientific Corp · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2005
Decision
21d
Days
Class 2
Risk

K051679 is an FDA 510(k) clearance for the ILAB ULTRASOUND IMAGING SYSTEM. Classified as Catheter, Ultrasound, Intravascular (product code OBJ), Class II - Special Controls.

Submitted by Boston Scientific Corp (Fremont, US). The FDA issued a Cleared decision on July 14, 2005 after a review of 21 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1200 - the FDA cardiovascular device oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Boston Scientific Corp devices

Submission Details

510(k) Number K051679 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 23, 2005
Decision Date July 14, 2005
Days to Decision 21 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
104d faster than avg
Panel avg: 125d · This submission: 21d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code OBJ Catheter, Ultrasound, Intravascular
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1200
Definition For Intracardiac And Intraluminal Visualization Of Cardiovascular Anatomy And Physiology.
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 - OBJ Catheter, Ultrasound, Intravascular

All 62
Devices cleared under the same product code (OBJ) and FDA review panel - the closest regulatory comparables to K051679.
ACUNAV DIAGNOSTIC ULTRASOUND CATHETER 8F AND 10F
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K051337 · Volcano Corporation · Aug 2005
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K050995 · Volcano Corporation · Jun 2005
ACUSON ACUNAV 8F ULTRASOUND CATHETER
K042593 · Siemens Medical Solutions USA, Inc. · Oct 2004
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K041727 · Boston Scientific Scimed, Inc. · Jul 2004