Cleared Abbreviated

ULTRASOUND SCANNER SYSTEM BK2300 (K140428) - FDA 510(k) Clearance

Class II Radiology device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K140428 · B-K Medical Aps · Radiology device
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May 2014
Decision
100d
Days
Class 2
Risk

K140428 is an FDA 510(k) clearance for the ULTRASOUND SCANNER SYSTEM BK2300. Classified as System, Imaging, Pulsed Echo, Ultrasonic (product code IYO), Class II - Special Controls.

Submitted by B-K Medical Aps (Herlev, DK). The FDA issued a Cleared decision on May 30, 2014 after a review of 100 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1560 - the FDA radiology and imaging software oversight framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all B-K Medical Aps devices

Submission Details

510(k) Number K140428 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 19, 2014
Decision Date May 30, 2014
Days to Decision 100 days
Submission Type Abbreviated
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
7d faster than avg
Panel avg: 107d · This submission: 100d
Pathway characteristics
Standards-based clearance path.

Device Classification

Product Code IYO System, Imaging, Pulsed Echo, Ultrasonic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1560
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.

Regulatory Peers - IYO System, Imaging, Pulsed Echo, Ultrasonic

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