EDAN Nano L12 EXP Diagnostic Ultrasound System

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

The Nano Series, including the Nano L12 EXP, 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 notes “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 EXP is built around a 64-physical-channel linear array with 192 elements, operating at a frequency range of 4–12 MHz and maximum scanning depth of 10 cm—parameters oriented toward superficial and high-resolution applications such as peripheral vascular assessment, musculoskeletal imaging, small-parts evaluation, nerve identification, lung surface imaging, and needle guidance . The transducer is IP67-rated for dust and water resistance, weighs approximately 215 g, measures 161 × 64 × 29 mm, and operates for up to 5 hours (50% scanning / 50% pause) on its internal battery, with a charge time of approximately 2.5 hours from 8% to 90% .

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, Body Mark, Measurement tools, Screen Switching, Multi-Language support, eLearn Guidance, and DICOM Transfer . Optional licenses add Auto B-Line (lung assessment), eVocal (voice annotation), and eBladder (bladder volume), with a needle guide bracket (BGK-017) available for in-plane procedural guidance. The system connects to Android devices (minimum Android 10), and DICOM, JPEG, and MP4 export supports integration with PACS and practice-management workflows where configured .

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

Key Features & Benefits

64-Channel Linear Array for High-Resolution Superficial Imaging

The Nano L12 EXP’s 64 physical channels and 192-element linear array operate across a 4–12 MHz frequency range with maximum depth of 10 cm . This configuration is optimized for superficial structures and fine detail—vessels, thyroid, breast, testicular tissue, musculoskeletal interfaces, nerves, and lung surface—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 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 from 8% to 90%, reducing dependence on mains power during mobile, emergency, or field use.

Wireless or Wired Connectivity to Android Devices

The Nano L12 EXP communicates with the EDAN Nano app on Android tablets and smartphones (minimum Android 10) 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 . Local storage and sharing via Bluetooth, AirDrop, and third-party applications are referenced in distributor documentation, supporting consultation and recordkeeping without a dedicated workstation.

Workflow Automation: Auto B-Line, eVocal, and Auto Optimization

The Nano L12 EXP includes Auto Trace, Dual Imaging, and B/C/PW Auto Optimization, supporting efficient image acquisition and measurement with reduced manual adjustment . Optional Auto B-Line provides a navigation protocol for lung condition assessment, and optional eVocal enables voice control for hands-free workflow adjustment . 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

A needle guide bracket (BGK-017, in-plane) is available for the Nano L12 EXP, supporting ultrasound-guided needle visualization during procedures such as vascular access, nerve blocks, and soft-tissue aspiration . The linear array’s high-frequency resolution and real-time needle enhancement (where configured) are intended to support procedural accuracy within the clinician’s scope of practice.

Compact, Single-Hand Form Factor

The Nano L12 EXP 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 EXP?