Cleared Abbreviated

K151910 - Ultrasound Scanner System BK2300

K151910 is an FDA 510(k) clearance for Ultrasound Scanner System BK2300, manufactured by Bk Medical Aps. The device is a Class 2 Radiology device with product code IYN cleared through the Abbreviated 510(k) pathway after a 84-day FDA review.

K151910 · Bk Medical Aps · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2015
Decision
84d
Days
Class 2
Risk

K151910 is an FDA 510(k) clearance for the Ultrasound Scanner System BK2300. Classified as System, Imaging, Pulsed Doppler, Ultrasonic within the IYN classification (a category covering pulsed Doppler and ultrasound imaging systems), Class II - Special Controls.

Submitted by Bk Medical Aps (Herlev, DK). The FDA issued a Cleared decision on October 5, 2015 after a review of 84 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1550 - 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 Bk Medical Aps devices

FDA 510(k) Submission Details - K151910

510(k) Number K151910 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 13, 2015
Decision Date October 05, 2015
Days to Decision 84 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
23d faster than avg
Panel avg: 107d · This submission: 84d
Pathway characteristics
Standards-based clearance path.

IYN Device Classification - Class 2, Special Controls

Product Code IYN System, Imaging, Pulsed Doppler, Ultrasonic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1550
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 - IYN System, Imaging, Pulsed Doppler, Ultrasonic

All 874
Devices cleared under the same product code (IYN) and FDA review panel - the closest regulatory comparables to K151910.
M9/M9CV/M9T Diagnostic Ultrasound System
K152543 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Oct 2015
Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound System
K152763 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Oct 2015
ULTRASOUND SYSTEM SONIMAGE HS 1
K152577 · Konica Minolta, Inc. · Oct 2015
DC-60/DC-60S/DC-60 EXP/DC-55 Diagnostic Ultrasound Systems
K152545 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Oct 2015
LOGIQ S8
K152195 · Ge Healthcare · Sep 2015
LOGIQ E9, LOGIQ E9 XDClear 2.0
K152309 · GE Medical Systems Ultrasound and Primary Care Diagnostics · Sep 2015