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bk2300

FDA 510(k)

Class II (US FDA 510(k))

510(k) K161960

by Bk Medical ApS

Identifiers

510(k) Number
K161960 FDA 510(k)
FDA Product Code
IYN FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 892.1550 FDA 510(k)
Regulation Number
892.1550 FDA 510(k)
Advisory Committee
Radiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The BK2300 is a diagnostic ultrasound imaging system classified as a portable ultrasound scanner. It is designed for visualising internal body structures and conducting fluid flow analysis using advanced imaging modes such as B-mode, Tissue Harmonic Imaging, M-mode, Pulsed-Wave Doppler (PWD), Continuous-Wave Doppler (CWD), and Color Doppler.

This system is intended for use in clinical radiology settings by trained professionals. It is supplied as a reusable device, with optional battery power for extended use, and is authorised under FDA 510(k) clearance (K161960) as substantially equivalent to a predicate device. No specific sterility or MRI safety information is provided in the available data.

Frequently asked questions

What types of imaging and Doppler analysis can the BK2300 perform, and why is this important for clinical use?

The BK2300 supports multiple imaging modes including B-mode for static anatomical visualization, Tissue Harmonic Imaging for improved contrast and reduced artifacts, and M-mode for motion assessment over time. For fluid flow analysis, it offers Pulsed-Wave Doppler (PWD), Continuous-Wave Doppler (CWD), and Color Doppler, which are critical for evaluating blood flow, cardiac function, and vascular conditions. These capabilities make it versatile for general radiology, cardiology, and vascular assessments in clinical settings.

Is the BK2300 designed for use in environments where portability is a priority, and how does the battery option enhance its functionality?

Yes, the BK2300 is explicitly described as a portable ultrasound scanner, allowing clinicians to perform imaging at patient bedsides or in non-radiology areas. The optional battery power extends its operational time beyond standard AC power, ensuring continuous use during procedures or in locations without reliable electrical outlets, which is particularly useful in emergency or mobile settings.

How is the BK2300 intended to be used in clinical practice, and what training is implied for operators?

The BK2300 is intended for use in clinical radiology settings by trained professionals, meaning it requires operators with ultrasound expertise—such as radiologists, sonographers, or specialized nurses—to interpret images and perform Doppler analyses accurately. Its advanced imaging modes (e.g., Color Doppler) suggest it is not for point-of-care use by untrained staff but rather for structured diagnostic evaluations.

What does the reusable classification of the BK2300 imply for maintenance and infection control in a healthcare facility?

Since the BK2300 is classified as a reusable device, healthcare facilities must follow established protocols for cleaning, disinfection, and sterilization between uses to prevent cross-contamination. This includes adhering to manufacturer guidelines (if available) and facility-specific policies for high-touch surfaces, probes, and internal components. Reusability also requires regular maintenance to ensure imaging quality and device longevity.

What regulatory pathway was followed for the BK2300’s FDA clearance, and what does this mean for its clinical adoption?

The BK2300 received FDA 510(k) clearance (K161960) under the Traditional 510(k) pathway, determined to be substantially equivalent to a predicate device in the Radiology category (reviewed by the Radiological Devices Advisory Committee). This clearance indicates the device meets U.S. safety and performance standards for its intended diagnostic uses, allowing clinicians and facilities to adopt it with confidence in its regulatory compliance for ultrasound imaging and Doppler analysis.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Bk Medical ApS 2300 bk3000, bk3500 & bk5000 Ultrasound System - RevMed, Ultrasound Scanner System bk2300 - healthcareequipment.org, BK Medical BK2300 Ultrasound Scanner | myHealthbox

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Bk Medical ApS

Sources (1)

  • FDA 510(k) K161960 24 fields · synced Sep 19, 2026