EDAN Acclarix AX7 Diagnostic Ultrasound System

The EDAN Acclarix AX7 is a compact, cart-optional diagnostic ultrasound system engineered for point-of-care and general imaging applications in hospitals, clinics, and mobile care settings. It is built on a 128-physical-channel architecture with a 15-inch HD anti-glare monitor that tilts and swivels, dual gesture-driven touchscreens, a fully sealed control panel for infection control, and an extended battery for use away from mains power.

The Acclarix AX7 is FDA-cleared as part of the Acclarix AX8 Series under 510(k) K250214 (February 20, 2025) , Class II, 21 CFR 892.1550, Product Code IYN. The clearance explicitly lists “Acclarix AX7” as a covered model within the device name. The cleared intended use states the system is “intended for use by a qualified physician or allied health professional for ultrasound evaluations in hospitals and clinics” , with clinical applications including Abdominal, Gynecology, Obstetric, Cardiac, Small parts, Urology, Peripheral vascular, Musculoskeletal, Pediatric, Neonatal, Adult Cephalic, Thoracic/Pleural, and Trans-esophageal Cardiac. The modes of operation include B mode, M mode, Doppler mode, Harmonic Imaging, Elastography Imaging, Contrast Imaging, and their combination modes.

Critically, the FDA summary for K250214 states “No clinical data” ; substantial equivalence was supported by bench testing, functional/system-level validation, and software verification per FDA guidance, with compliance confirmed for IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, and IEC 60601-2-18. This means the device’s regulatory clearance is based on non-clinical performance and safety testing, not prospective clinical endpoint studies.

The standard imaging package includes Tissue Adaptive Imaging, Harmonic Imaging, Spatial Compound Imaging, eSRI (Speckle Reduction Imaging) , Color Doppler / Power Doppler / Directional Power Doppler, and Pulsed Wave Doppler. Optional licenses add TDI (Tissue Doppler Imaging) , Anatomical M, CW Doppler, Needle Visualization, Panorama Imaging, Advanced DICOM, Auto IMT, 3D/4D, and Wi-Fi. The system supports a broad transducer portfolio—including the L17-7HQ high-frequency linear, C5-2XQ convex, P5-1XQ phased array, and E8-4Q endocavity—alongside needle guide brackets for procedural guidance and an MT-809 height-adjustable trolley for cart-based deployment.

The Acclarix AX7 is built for clinicians who need a compact, shared-service ultrasound platform—one system capable of supporting abdominal, OB/GYN, MSK, vascular, cardiac, and procedural imaging across multiple care settings, with a workflow designed for efficiency and infection control in point-of-care environments.

Key Features & Benefits

128-Physical-Channel Architecture with One-Key Optimization

The 128 physical channels provide the system’s signal acquisition foundation for high-fidelity detail resolution, particularly at depth. The Acclarix AX7 includes continuous, automatic image optimization designed to reduce the need for manual control adjustments during scanning—supporting consistent image quality across users and clinical scenarios. Tissue Adaptive Imaging and eSRI speckle reduction work alongside Spatial Compound Imaging and Harmonic Imaging to support border definition and contrast resolution in superficial and deep structures alike.

FDA-Cleared for Thirteen Clinical Applications

The K250214 clearance covers Abdominal, Gynecology, Obstetric, Cardiac, Small parts, Urology, Peripheral vascular, Musculoskeletal, Pediatric, Neonatal, Adult Cephalic, Thoracic/Pleural, and Trans-esophageal Cardiac applications. This breadth means a single Acclarix AX7 configuration can support focused assessment across multiple body regions—from abdominal and obstetric imaging through MSK, vascular, and cardiac applications—within the scope of the clinician’s training and the installed transducer set.

15-Inch HD Anti-Glare Monitor with Tilt-and-Swivel Design

The 15-inch HD monitor with hard glass and anti-glare treatment tilts and swivels to support optimal viewing during procedures and across different scanning positions. The monitor is paired with dual gesture-driven touchscreens that allow direct control of imaging parameters and menus, and a fully sealed control panel that aids in infection control by simplifying cleaning and disinfection between patients.

Extended Battery and Compact Form Factor

The system includes a rechargeable lithium-ion battery (6150 mAh) that supports extended operation away from mains power, making it suitable for point-of-care, bedside, and mobile use where a power outlet may not be immediately available. The compact main unit can be used standalone or mounted on the MT-809 height-adjustable trolley, supporting both bedside deployment and cart-based workflow as clinical needs require.

Broad Transducer Portfolio and Needle Guidance

The Acclarix AX7 accepts a wide range of transducers covering superficial, abdominal, cardiac, and endocavitary imaging. Key transducers include the L17-7HQ high-frequency linear (for MSK, nerve, vascular, and small parts), the C5-2XQ convex (abdominal, OB/GYN), the P5-1XQ phased array (cardiac), and the E8-4Q endocavity array. Needle guide brackets are available for select transducers (in-plane and out-of-plane configurations), supporting ultrasound-guided needle visualization during procedures.

Optional Licenses for Advanced Workflows

Optional licenses extend the platform into Tissue Doppler Imaging (TDI) , Anatomical M-mode, CW Doppler for higher-velocity cardiac flow, Needle Visualization enhancement, Panorama Imaging for extended field-of-view reconstruction, Auto IMT for carotid intima-media thickness, 3D/4D imaging, and Advanced DICOM (Modality Worklist, Structured Report, MPPS, Print, Storage Commitment, Query/Retrieve). These options allow departments to configure the system to their specific clinical and connectivity requirements without replacing the core platform.

Connectivity and Workflow Integration

The system includes an integrated 500 GB hard drive (120 GB configuration also available) and four USB ports for image archiving and export. Advanced DICOM is available as an optional license, supporting worklist integration, structured reporting, and PACS connectivity for paperless workflow where the infrastructure exists. Wi-Fi is also available as an optional module.

Regulatory Status: FDA-Cleared Platform with Bench-Tested Equivalence

The Acclarix AX7 is FDA-cleared under K250214 (Class II, IYN) as part of the Acclarix AX8 Series, with AX7 explicitly listed as a covered model. The clearance relied on bench testing and software validation rather than clinical endpoint studies, and the system complies with IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, and IEC 60601-2-18. Availability and cleared claims vary by market; confirm local registration and labeling before purchase.

Technical Specifications

Why Choose the EDAN Acclarix AX7?