Cleared Special

Ultrasound Scanner System bk2300 (K152052) - FDA 510(k) Clearance

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

K152052 · Bk Medical Aps · Radiology device
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Sep 2015
Decision
55d
Days
Class 2
Risk

K152052 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 September 16, 2015 after a review of 55 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. 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 Bk Medical Aps devices

Submission Details

510(k) Number K152052 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 23, 2015
Decision Date September 16, 2015
Days to Decision 55 days
Submission Type Special
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
52d faster than avg
Panel avg: 107d · This submission: 55d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 632
Devices cleared under the same product code (IYN) and FDA review panel - the closest regulatory comparables to K152052.
Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound System
K152763 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 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
DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S
K150080 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Jun 2015
DC-70/DC-70T/DC-70 PRO/DC-70 EXP Diagnostic Ultrasound Systems
K150204 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Apr 2015
Voluson E6 / Voluson E8 / Voluson E10 Diagnostic Ultrasound Systems
K142472 · Ge Healthcare · Feb 2015