Ultrasound System 1300
Regulatory Status Disclosed
Overview
The BK Medical Ultrasound System 1300, marketed as bkSpecto, is a mobile, software-controlled diagnostic ultrasound system. It is designed for use by qualified healthcare professionals in various clinical environments, including hospitals and physician offices.
- What it does: The system provides 2D and 3D ultrasound imaging, fluid flow analysis, and guidance for puncture and biopsy procedures. It offers multiple scanning modes, including B-mode (with Tissue Harmonic Imaging, Vector Flow Imaging (VFI), Elastography, and Contrast Imaging), M-mode, Pulsed Wave Doppler (PWD), and Color Flow Mapping (CFM) Doppler.
- Who it is for: The Ultrasound System 1300 is intended for a broad range of specialties and applications, such as urology, vascular, cardiology, OB/GYN, emergency medicine, surgery, anesthesia, abdominal, pediatric, small organ, adult and neonatal cephalic, intra-operative (including neuro), trans-rectal, trans-vaginal, musculoskeletal, and peripheral vessel imaging.
- How it fits a clinical or practice workflow: The system is designed for mobility within procedure rooms and features a customizable, touch-screen interface for workflow personalization. It supports a variety of sterilizable transducers and can be integrated with specialized puncture attachments for biopsies and seed implantation. An optional 3D unit can reconstruct 2D images into a 3D volume.
- Notable capabilities: Key features include advanced imaging modes like VFI and Elastography, Contrast Imaging, and an AI software feature called Prostate Volume Assist (PVA). The system also incorporates a sealed glass interface for cleaning and infection control, and some configurations include an integrated battery for portability.
Reviewed by Pouyan Golshani, MD — Interventional Radiologist
What Physicians Need to Know
DICOM Support & Standards
The Ultrasound System 1300 (bkSpecto) features DICOM as an advanced technology and performance mode, supporting digital communications of medical information. Its development aligns with NEMA PS3.1 u2013 3.20 Digital Imaging and Communications in Medicine (DICOM) standards.
PACS Integration Method
The system supports PACS integration through its DICOM capabilities and 10/100 Ethernet connectivity. BK Medical is actively researching the integration of its standalone ultrasound systems into distributed hospital systems, indicating a focus on robust data management and connectivity.
Reading Room Workflow Impact
The bkSpecto is designed for an intuitive, personalized workflow with an easy-to-use interface and touchscreen, enabling faster training and procedures. It enhances diagnostic accuracy and workflow efficiency through high-resolution imaging and rapid, touch-based operations. The system can store over 20,000 patient records and includes features like automatic prostate density calculation to streamline physician tasks.
AI Model Architecture (deep learning approach)
The Ultrasound System 1300 includes an AI software feature called 'Prostate Volume Assist (PVA)'. This feature utilizes a deep learning approach, with clinical validation involving training, validation, and test datasets from healthy and diseased patients, as well as synthesized data.
FDA Clearance Pathway (510k/De Novo)
The Ultrasound System 1300 (bkSpecto) received FDA clearance via the 510(k) premarket notification pathway (K173569) as a Class II device. The 'Prostate Volume Assist (PVA)' AI software feature was added to the system, also cleared through the 510(k) pathway as an enhancement.
Supported Modalities (CT/MRI/X-ray/US)
The Ultrasound System 1300 is a dedicated ultrasound system, supporting various ultrasound modes including B, M, D (PWD), C (Color Flow Mapping), Tissue Harmonic Imaging, Vector Flow Imaging (VFI), Elastography, Contrast Imaging, CW Doppler, and 3D. It is designed for a wide range of clinical applications such as Urology, Vascular, OB/GYN, Emergency Medicine, Surgery, and Anesthesia.
RSNA/ACR Validation
No direct mention of formal RSNA or ACR validation for the Ultrasound System 1300 or its integrated AI features was found in the provided information. Clinical validation for the AI feature is noted in FDA documents.
Physician Tip
Leverage the intuitive touchscreen interface and customizable workflow to optimize exam efficiency, especially for urology, colorectal, and pelvic floor procedures. Utilize the integrated Prostate Volume Assist (PVA) AI feature to streamline prostate volume measurements and calculations, potentially reducing manual steps and improving consistency. Ensure proper DICOM configuration for seamless image transfer to PACS, facilitating efficient review and archiving. The system's mobility and quick boot-up time make it suitable for various point-of-care and interventional settings.
The Ultrasound System 1300 offers robust DICOM support for standard PACS integration, ensuring compatibility with existing imaging infrastructure. Its Ethernet connectivity further enables network integration. BK Medical's ongoing research into distributed system architectures suggests future-proofing for broader hospital system and IoT integration. While primarily a standalone ultrasound system, its high-quality DICOM output and potential for external data fusion (e.g., with MRI in neurosurgery) make it a valuable component in a comprehensive imaging workflow.
Details
| Category | Radiology & Imaging AI, Surgical AI |
| Pricing | Unknown |
| Compliance | |
| BAA Available | Unknown AI-estimated |
| HIPAA Compliant | Unknown AI-estimated |
| FDA Status | Cleared AI-estimated |
| Integrations | |
| EHR | Not specified |
| Specialties | Cardiology, Obstetrics & Gynecology, Radiology |
Ratings & Reviews
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Press & Coverage
GlobalData
BK Medical Receives Additional 510(K) Clearance for Ultrasound System 1300
BK Medical received an additional 510(k) clearance for its Ultrasound System 1300 in November 2023, as noted in a pipeline market report.
2023-11
accessdata.fda.gov
Ultrasound System 1300 510(k) Clearance (K231764)
The FDA granted 510(k) clearance for the BK Medical Ultrasound System 1300 on October 23, 2023, detailing its intended use as a multi-purpose mobile diagnostic ultrasound system for various clinical applications.
2023-10
X-ray Interpreter
Ultrasound System 1300 | FDA Radiology AI Device
The Ultrasound System 1300 by BK Medical ApS is a mobile ultrasound system designed for diagnostic imaging and fluid flow analysis across multiple clinical applications.
2023-10
accessdata.fda.gov
Class 2 Device Recall bk medical - Ultrasound System 1300, bkSpecto w/battery
A Class 2 Device Recall was issued for the Ultrasound System 1300, bkSpecto with battery, due to inadequate instructions for battery replacement intervals, end-of-life handling, and general battery safety precautions.
2025-11
ManualsLib
BK MEDICAL BKSPECTO 1300 SERVICE MANUAL Pdf Download
The service manual for the BK Medical bkSpecto 1300 Diagnostic Ultrasound System provides detailed information on general operation, service notes, troubleshooting, and maintenance procedures.
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Scribd
Spesifikasi BK Ultrasound Scanner System - BK Specto - For Urology
A document detailing the specifications of the BK Ultrasound Scanner System, specifically the BK Specto (Ultrasound System 1300) for urology applications, highlights its features like a touchscreen, glass keyboard, and various scanning modes.
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Videos
Product demos, reviews, and walkthroughs for Ultrasound System 1300.
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Frequently Asked Questions
The AI in System 1300 is designed to optimize image quality during acquisition, potentially reducing scan times and improving consistency. It also offers AI-powered tools for automated measurements and preliminary lesion characterization, aiming to support the physician's diagnostic process.
The AI algorithms within the Ultrasound System 1300 have received relevant regulatory clearances (e.g., FDA 510(k) or CE Mark) for their intended use as a diagnostic aid. The system incorporates robust data encryption and anonymization protocols to comply with HIPAA, GDPR, and other relevant patient data privacy regulations.
The system employs on-device AI processing where feasible to minimize data transfer, and any necessary cloud interactions are secured with end-to-end encryption and anonymization techniques. Data access is strictly controlled, adhering to industry-standard security frameworks and healthcare privacy regulations like HIPAA and GDPR.
The Ultrasound System 1300's AI focuses on real-time image optimization and specific organ analysis, differentiating it from systems that might prioritize other AI applications. While traditional methods rely solely on operator expertise, our AI aims to augment that expertise, potentially improving efficiency and reproducibility.
The core AI features for image enhancement and basic measurements are integrated into the Ultrasound System 1300's base price. Advanced AI modules for specialized applications may be offered as optional upgrades or subscription services, impacting the total cost based on selected functionalities.
The AI is a decision-support tool and and may have limitations in atypical cases or with rare pathologies, reflecting the data it was trained on. Physicians retain full responsibility for final diagnoses and treatment decisions, as the AI's output is intended to assist, not replace, clinical judgment.
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| Last Verified: 2026-04-20 | First Added: 2026-04-20