Cleared Special

K042619 - ULTRABIO - IN VIVO BIOCOMPATIBLE, BIOELIMINATED STERILE ULTRASOUND IMAGING COUPLANT

K042619 is an FDA 510(k) clearance for ULTRABIO - IN VIVO BIOCOMPATIBLE, manufactured by Sonotech, Inc.. The device is a Class 2 Radiology device with product code MUI cleared through the Special 510(k) pathway after a 42-day FDA review.

K042619 · Sonotech, Inc. · Radiology device
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Nov 2004
Decision
42d
Days
Class 2
Risk

K042619 is an FDA 510(k) clearance for the ULTRABIO - IN VIVO BIOCOMPATIBLE, BIOELIMINATED STERILE ULTRASOUND IMAGING CO.... Classified as Media, Coupling, Ultrasound (product code MUI), Class II - Special Controls.

Submitted by Sonotech, Inc. (Bellingham, US). The FDA issued a Cleared decision on November 5, 2004 after a review of 42 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1570 - the FDA radiology and imaging software 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.

FDA 510(k) Submission Details - K042619

510(k) Number K042619 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 24, 2004
Decision Date November 05, 2004
Days to Decision 42 days
Submission Type Special
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
65d faster than avg
Panel avg: 107d · This submission: 42d
Pathway characteristics
Modification to existing cleared device.

MUI Device Classification - Class 2, Special Controls

Product Code MUI Media, Coupling, Ultrasound
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1570
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 Radiology devices follow this clearance model.

K042619 · ULTRABIO - IN VIVO BIOCOMPATIBLE, BIOELIMINATED STERILE ULTRASOUND IMAGING COUPLANT
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