EDAN Nano L12 Diagnostic Ultrasound System

The EDAN Nano L12 is a handheld, app-based linear array ultrasound system designed for high-resolution imaging of superficial structures—vascular, musculoskeletal, small parts, and procedural guidance—at the point of care. It is the 32-physical-channel linear configuration within EDAN’s Nano Series, distinguished from the 64-channel Nano L12 EXP by its channel count and processing architecture, and it communicates wirelessly or via cable with an iOS or Android tablet or smartphone running the EDAN Nano app.

The Nano Series, including the Nano L12, received FDA 510(k) clearance under K251268 (December 23, 2025) as a Class II ultrasonic pulsed Doppler imaging system (21 CFR 892.1550; Product Codes IYN, IYO, ITX). The cleared intended use states the system is intended for use by an appropriately trained and qualified healthcare professional for ultrasound evaluation in hospitals, clinics, road ambulances, or at home, with clinical applications covering Abdominal, Gynecology, Obstetric, Small parts, Musculoskeletal, Urology, Peripheral vascular, Pediatric, Pleural/Thoracic, and Cardiac imaging. The FDA summary explicitly states “No clinical data”; substantial equivalence was established through bench testing, electrical safety (IEC 60601-1), EMC (IEC 60601-1-2), and ultrasound-specific safety standards (IEC 60601-2-37), alongside software verification and validation.

The Nano L12 is built around a 32-physical-channel linear array with 128 elements, operating across a frequency range of approximately 4–12 MHz and supporting maximum scanning depth in the superficial range (up to 10 cm)—parameters oriented toward vascular access, musculoskeletal assessment, small-parts evaluation, and nerve identification. The transducer is IP67-rated for dust and water resistance, weighs approximately 215 g, and measures 161 × 64 × 29 mm, with up to 5 hours of battery life (50% scanning / 50% pause) and a charge time of approximately 2.5 hours.

The standard software package includes B-mode, M-mode, Color mode, and Pulsed Wave (PW) Doppler, alongside SynSight synthetic focused sonography, TAI tissue adaptive imaging, eSRI speckle reduction, Auto Trace, Dual Imaging, B/C/PW Auto Optimization, Pan/Digital Zoom, Full Screen Zoom, and eLearn guidance. Optional licenses add eVocal (voice annotation), eDiam (vessel diameter measurement), Auto IMT (intima-media thickness), eVol.Flow (volume flow), Live.VF (live video), and eStensto% (stenosis percentage)—each addressing a specific vascular or procedural workflow. A needle guide bracket (BGK-018/019, in-plane or out-of-plane) is available for ultrasound-guided needle visualization, and the MT-320 trolley provides a cart-based docking option.

The Nano L12 is built for point-of-care ultrasound (POCUS) users—emergency and critical care clinicians, anesthesiologists, musculoskeletal and vascular specialists, primary care practitioners, and mobile care teams—who need high-resolution superficial imaging capability without the footprint, cost, or power dependency of a cart-based system.

Key Features & Benefits

32-Channel Linear Array for High-Resolution Superficial Imaging

The Nano L12’s 32 physical channels and 128-element linear array operate across a 4–12 MHz frequency range with superficial depth penetration up to 10 cm. This configuration is optimized for superficial structures and fine detail—peripheral vessels, thyroid, breast tissue, musculoskeletal interfaces, and nerves—where higher frequency and higher resolution are clinically valuable. The linear form factor supports broad footprint contact for vascular and MSK scanning, and needle guide brackets enable in-plane or out-of-plane procedural guidance.

FDA-Cleared for Ten Clinical Applications and Multiple Care Settings

The K251268 clearance covers Abdominal, Gynecology, Obstetric, Small parts, Musculoskeletal, Urology, Peripheral vascular, Pediatric, Pleural/Thoracic, and Cardiac applications, with intended use explicitly extending to hospitals, clinics, road ambulances, and home environments. While the linear array is most directly applied to superficial and procedural imaging, the cleared application breadth means the same device can support focused assessment across multiple body regions within the scope of the clinician’s training and the device’s physical capabilities.

IP67 Waterproof and 5-Hour Battery for Point-of-Care Use

The transducer is IP67-rated for dust and water resistance, supporting cleaning and use in demanding clinical and field environments. At approximately 215 g and 161 × 64 × 29 mm, it is designed for single-hand scanning and pocket-carried transport. The internal battery supports up to 5 hours of use (50% scanning / 50% pause) and charges in approximately 2.5 hours, reducing dependence on mains power during mobile, emergency, or field use.

Wireless or Wired Connectivity to iOS and Android Devices

The Nano L12 communicates with the EDAN Nano app on iOS or Android devices via USB-C cable or wireless connection. The app provides B-mode, M-mode, Color, and PW Doppler imaging, along with DICOM/JPEG/MP4 export for archiving and sharing where configured. Local storage and sharing via Bluetooth and third-party applications are referenced in distributor documentation, supporting consultation and recordkeeping without a dedicated workstation.

Workflow Automation: Auto Trace, Dual Imaging, and Optional Vascular Licenses

The Nano L12 includes Auto Trace, Dual Imaging, and B/C/PW Auto Optimization, supporting efficient image acquisition and measurement with reduced manual adjustment. Optional vascular licenses—eDiam, Auto IMT, eVol.Flow, Live.VF, and eStensto%—extend the platform into vessel diameter, intima-media thickness, volume flow, and stenosis assessment workflows for clinicians who require those specific measurements. These tools are presented as workflow aids—they support the clinician’s image review and procedure, and do not replace clinical judgment.

Needle Guidance and Procedural Support

Needle guide brackets (BGK-018 for in-plane, BGK-019 for out-of-plane) are available for the Nano L12, supporting ultrasound-guided needle visualization during procedures such as vascular access, nerve blocks, and soft-tissue aspiration. The linear array’s high-frequency resolution is intended to support procedural accuracy within the clinician’s scope of practice.

Compact, Single-Hand Form Factor

The Nano L12 shares the Nano Series enclosure at approximately 161 × 64 × 29 mm and 215 g, with the transducer, battery, and wireless electronics integrated into the handle. This form factor supports pocket-carried deployment, rapid setup between patients, and use in space-constrained environments such as ambulances, examination rooms, and bedside settings where a cart-based system would be impractical.

Technical Specifications

Why Choose the EDAN Nano L12?