Ultrasound System 2300

by BK Medical (a GE HealthCare company)  · Based in United States → — Surgical Visualization and Guidance / Precision ultrasound. Right where you need it.
General Surgery Radiology Urology
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Regulatory Status Disclosed

Overview

The Ultrasound System 2300 by BK Medical Aps is a multi-purpose, mobile, and software-controlled diagnostic ultrasound system designed for a wide range of clinical applications. It offers advanced imaging capabilities for diagnostic ultrasound imaging and fluid flow analysis of the human body, as well as guidance for puncture and biopsy procedures. The system features various imaging modes including B-mode, Tissue and Contrast Harmonic Imaging, M-mode, Pulsed Wave Doppler (PWD), Continuous Wave Doppler (CWD), Color Doppler, Vector Flow Imaging (VFI), and Elastography. An optimal 3-D unit can reconstruct a series of 2-D images into a single 3-D volume. The system consists of a mobile console with digital acquisition, processing, and display capabilities, and a user interface that can include a conventional keyboard or a glass touchpad. It is available in different configurations, such as bk3000, bk5000, and bkActiv, each tailored for specific applications. BK Medical emphasizes its technology for Active Imaging, based on real-time intraoperative ultrasound, to provide surgeons with immediate visual guidance.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • Diagnostic ultrasound imaging and fluid flow analysis
  • Multiple imaging modes: B, M, PWD, CWD, Color Doppler, VFI, Elastography, Tissue and Contrast Harmonic Imaging
  • Guidance for biopsy needles and puncture procedures
  • 3-D unit for reconstructing 2-D images from 2-D series
  • Optional RF wireless function for printing and archive connectivity
  • Mobile console with digital acquisition, processing, and display capabilities
  • User interface with conventional keyboard or glass touchpad options
  • Available in various configurations (bk3000, bk5000, bkActiv) for specialized use
  • Sterilizable and easy-to-disinfect transducers and systems
  • Rapid boot time and up to two hours of plug-free imaging (configuration dependent)

Use Cases

  • Urology procedures and diagnostics
  • General imaging examinations
  • Intra-operative surgical guidance (e.g., neurosurgery, colorectal, laparoscopic)
  • Anesthesiology applications
  • Fetal (obstetrics), abdominal, and pediatric imaging
  • Puncture and biopsy guidance

What Physicians Need to Know

DICOM Support & Standards
The Ultrasound System 2300 supports DICOM (Digital Imaging and Communications in Medicine) standards, specifically NEMA PS3.1 – 3.20. DICOM is a registered trademark of the National Electrical Manufacturers Association for its standards publications relating to digital communications of medical information. The system allows for configuration of DICOM Host settings.
PACS Integration Method
BK Medical has been engaged in research to integrate its standalone ultrasound systems into multiple distributed systems, including hospital care systems and research laboratories. The system's architecture is evolving to be more readily integrable into hospital care systems. The bkViewer 3D Architecture, associated with BK Medical, allows for easy export to DICOM-compatible systems.
Reading Room Workflow Impact
The system is designed for real-time imaging during procedures, providing immediate feedback for surgeons and interventionalists. Features like Prism imaging, Auto Gain, and Auto Focus are intended to optimize images quickly without constant manual adjustment, which can streamline workflow. The system aims to provide greater integration into patient care systems to facilitate improved decision-making for doctors.
AI Model Architecture (deep learning approach)
While the Ultrasound System 2300 itself is a diagnostic ultrasound system, BK Medical's newer systems like bkActiv S Series are noted to offer AI-powered ultrasound. The company is building for the future with Artificial Intelligence capabilities.
FDA Clearance Pathway (510k/De Novo)
The Ultrasound System 2300 received FDA clearance through the 510(k) premarket notification pathway. The primary predicate device was the Ultrasound Scanner System bk2300 (K180737).
Supported Modalities (CT/MRI/X-ray/US)
The Ultrasound System 2300 is a diagnostic ultrasound imaging system. It supports various ultrasound imaging modes including 2D, M-mode, PW Doppler, CW Doppler, Color Doppler, Power Doppler, Harmonic Imaging, Coded Pulse, 3D/4D Imaging, Elastography, and Shear Wave Elastography.
Physician Tip

The BK Medical Ultrasound System 2300 is designed for real-time imaging, which is particularly beneficial for surgical and interventional procedures requiring immediate feedback. Its specialized probe selection is a significant advantage, especially for urology, surgery, and needle guidance. The system's advanced imaging tools, including elastography and various Doppler modes, can provide additional clinical information for assessing blood flow, tissue stiffness, and lesion characteristics. For optimal integration into existing hospital systems, ensure proper DICOM configuration and network setup.

The Ultrasound System 2300 supports DICOM standards for digital communication of medical information. BK Medical is actively working on integrating its ultrasound systems into broader hospital care systems and distributed environments. The system's architecture is evolving to facilitate easier integration with other healthcare IT infrastructure. The bkViewer 3D Architecture, associated with BK Medical, allows for easy export of 3D datasets to DICOM-compatible systems.

Details

Category Radiology & Imaging AI, Surgical AI
Pricing Unknown
DeploymentOn-premise (mobile system)
API AvailableUnknown
Data ExportUnknown
TrainingUnknown
Compliance
BAA Available Yes AI-estimated
HIPAA Compliant Yes AI-estimated
FDA Status Cleared AI-estimated
Integrations
EHR Not specified
Specialties General Surgery, Radiology, Urology

Support & Reliability

Training ProvidedUnknown

What the Web Says

The BK Medical Ultrasound System 2300 is a multi-purpose, software-controlled diagnostic ultrasound system designed for professional healthcare environments like hospitals and physician offices. It offers various configurations (including bk5000 and bkActiv) primarily intended for urology, general imaging, surgical, and anesthesiology applications. The system was cleared by the FDA in April 2023, with the application received in December 2022.

Overall: Mixed

Strengths

  • Multi-purpose diagnostic ultrasound system
  • Software-controlled with on-screen display for thermal and mechanical indices
  • Different configurations/models available for various applications (urology, general imaging, surgical, anesthesiology)
  • Intended for use in professional healthcare environments (hospitals, physician offices)
  • Can guide biopsy and puncture needles
  • Silicone keyboard for easy cleaning and disinfection

Limitations

  • Not intended for ophthalmic use or any use causing the acoustic beam to pass through the eye
  • Cardiac Adult application not intended for direct use on the heart
  • BK Medical does not take responsibility for computer viruses from hospital networks infecting the system
  • No reviews from physicians, healthcare IT, tech reviewers, Reddit, G2, or Capterra found
  • The software is not fault tolerant

Based on reviews from: fda.report, scribd.com, alpha.md, fda.gov, innolitics.com

Last updated: 2026-10-29

Ratings & Reviews

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Clinical Value
Ease of Use
Integration
Support & Docs
Value for Money

Press & Coverage

fda.gov
Class 2 Device Recall bkActiv Ultrasound System 2300
On January 25, 2024, the FDA announced a Class 2 Device Recall for the bkActiv Ultrasound System 2300 (models 2300-56 and 2300-66) due to a measurement error issue with the Dual Live Compare feature. BK Medical initiated the recall on November 30, 2023, and is correcting all affected products.
2024-01
fda.report
Ultrasound System 2300 510(k) K223830
The Ultrasound System 2300, manufactured by BK Medical Aps, received 510(k) clearance from the FDA on April 11, 2023, under number K223830, classifying it as a Class 2 device for diagnostic ultrasound imaging.
2023-04
fda.gov
510(k) Premarket Notification K222441 for Ultrasound System 2300
A 510(k) Premarket Notification for the Ultrasound System 2300 was submitted by BK Medical Aps, with the FDA listing the device classification as "System, Imaging, Pulsed Doppler, Ultrasonic" under regulation number 892.1550.
2026-10
fda.gov
Ultrasound System 2300 - Intended Use and Contraindications
The Ultrasound System 2300 is a multi-purpose diagnostic ultrasound system intended for urology, general imaging, surgical, and anesthesiology applications, but it is contraindicated for ophthalmic use or direct cardiac use.
2022-12

Videos

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Frequently Asked Questions

The BK Medical Ultrasound System 2300, particularly models like the bkActiv S Series, is designed with AI capabilities to enhance precision guidance in various procedures, including urology, colorectal, and pelvic floor applications. While specific AI features for radiology imaging on the 2300 are not extensively detailed, AI in ultrasound generally improves image quality, diagnostic accuracy, and clinical decision-making by analyzing complex medical images and assisting in automated detection and classification of diseases.
The Ultrasound System 2300 and its applications comply with voluntary standards such as ANSI/AAMI/ES 60601-: 2005/ (R) 2012 and A1:2012, C1:2009/ (R) 2012 and A2:2010/ (R) 2012 for medical electrical equipment safety, and IEC 60601-1-2: Ed. 4.0, 2014. It is intended for use in professional healthcare environments like hospitals and physician offices.
BK Medical ultrasound systems are primarily designed for intraoperative imaging, interventional procedures, and specialized applications such such as urology, colorectal surgery, neurosurgery, and minimally invasive surgery, rather than general diagnostic radiology. Therefore, alternatives would depend on the specific application, but general ultrasound producers create devices for a wider range of examinations, including abdominal sonography, obstetric ultrasound, and cardiology.
The Ultrasound System 2300 is not intended for ophthalmic use or any use where the acoustic beam passes through the eye, and the Cardiac Adult application is not intended for direct use on the heart. There have also been identified issues with internal power connections potentially coming loose in models with battery options (bk3000, bk3500, bk5000, and bkActiv 2300), which could lead to excessive heat or the device becoming inoperable. Additionally, an issue with the Dual Live Compare feature on the bkActiv 2300 system could result in a measurement error if the scanning depth in the Live image is not the same as the Stored image.
Specific pricing for the Ultrasound System 2300 and its AI-powered features is not publicly available and may vary. However, used BK Medical 2300-3500 ultrasound systems without a probe have been listed for sale at around $2,995.00 USD. For new systems and detailed pricing, it is best to contact BK Medical directly or an authorized distributor.

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Suggest an Edit → | Report an issue | Last Verified: 2026-04-17 | First Added: 2026-04-17
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