Ultrasound System 2300
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
Leverage the Ultrasound System 2300's AI-powered Prostate Volume Assist (PVA) for enhanced accuracy in prostate imaging and procedures. Utilize the intuitive, touch-based workflow and 'No Touch Auto Gain' features to streamline examinations and improve efficiency in the reading room. For interventional procedures, the system's advanced imaging algorithms and 'Predictive fusionu00ae tech' in bkFusion can provide precise guidance, especially when integrating with MRI data for biopsy targeting. The high-resolution imaging and various ultrasound modes (including 3D/4D and Elastography) offer comprehensive diagnostic capabilities across multiple applications.
The Ultrasound System 2300 offers robust DICOM 3.0 compliance, ensuring seamless integration with existing PACS and other DICOM-compatible systems for image archiving and communication. Its design supports future integration into broader distributed hospital systems and is 'AI-ready', indicating potential for expanded connectivity and data exchange within a healthcare IT ecosystem. The optional RF wireless function further enhances connectivity for printing and archiving purposes.
Details
| Category | Radiology & Imaging AI, Surgical AI |
| Pricing | Contact for pricing — N/A |
| Deployment | On-premise (hardware) |
| Compliance | |
| BAA Available | Yes AI-estimated |
| HIPAA Compliant | Yes AI-estimated |
| FDA Status |
Yes AI-estimated The Ultrasound System 2300 received 510(k) clearance (K223830) from the FDA on April 11, 2023. It is classified as a Class II medical device, intended for diagnostic ultrasound imaging, human body fluid flow analysis, and puncture and biopsy guidance. |
| Integrations | |
| EHR | Not specified |
| Specialties | General Surgery, Radiology, Urology |
What the Web Says
The BK Medical Ultrasound System 2300 is a versatile, mobile, software-controlled diagnostic ultrasound system designed for use by qualified healthcare professionals in various clinical applications, including urology, general imaging, surgical, and anesthesiology procedures. It features digital acquisition, processing, and display capabilities, with a user interface that can include a glass touchpad or a conventional keyboard and a 19-inch clinical display monitor. The system has received FDA clearance for its ultrasound workflow and includes features like speckle reduction, compound imaging, and tissue harmonic imaging.
Overall: MixedStrengths
- Versatile for various clinical applications (urology, general imaging, surgical, anesthesiology).
- Utilizes gaming technology for quickness and incredible image quality and color sensitivity.
- Offers different configurations (e.g., bkActiv with glass UI, bk5000 with conventional keyboard) to suit specific needs.
- Features like speckle reduction, compound imaging, and tissue harmonic imaging enhance image quality.
- Supports various transducers for different indicated uses.
- Capable of human body fluid flow analysis and puncture/biopsy guidance.
Limitations
- Potential for internal power connections to come loose in devices with battery option, leading to excessive heat or inoperability (recall initiated by GE HealthCare).
- An issue with the Dual Live Compare feature on the bkActiv system could result in a measurement error (recall initiated by firm).
- Not intended for ophthalmic use or any use causing the acoustic beam to pass through the eye.
- Cardiac Adult application is not intended for direct use on the heart.
- Keyboard panel is not watertight, requiring care to avoid spills.
- Modifying or installing unauthorized software voids warranty and service contracts.
Based on reviews from: BK Medical Aps radiology AI profile, Search FDA-cleared listings - Radiology AI Tools Directory, accessdata.fda.gov (K231764), Spesifikasi BK Ultrasound Scanner System - BK 5000 For Neurosurgery | PDF - Scribd, accessdata.fda.gov (December 7, 2022), accessdata.fda.gov (April 11, 2023), bk3500, bk3000, bk5000 & bkActiv 2300 Ultrasound Devices with battery option, bk3000 & bk5000 Ultrasound Systems - Frank's Hospital Workshop, bkActiv 2300 Ultrasound System User Guide - Manualzz, Class 2 Device Recall bkActiv Ultrasound System 2300 - accessdata.fda.gov, BK Ultrasound Demo - YouTube, Sheet1
Last updated: 2026-07-17
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