EDAN Nano C5 Portable Diagnostic Ultrasound System

The EDAN Nano C5 is a handheld, app-based diagnostic ultrasound system that places a complete convex-array imaging engine inside a transducer housing small enough to fit in a clinical coat pocket. Rather than integrating a display and processing console into a cart, the Nano C5 transmits acquired ultrasound data wirelessly or via cable to an iOS or Android smart device, where the EDAN Nano app renders B-mode, M-mode, Doppler, and harmonic imaging for review and documentation.

The Nano C5 is FDA-cleared under 510(k) K251268 (December 23, 2025) as a Class II ultrasonic pulsed Doppler imaging system (21 CFR 892.1550; Product Codes IYN, IYO, ITX) . The clearance explicitly covers the Nano C5, Nano C5 EXP, Nano L12, and Nano L12 EXP models. 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 C5 is the 32-physical-channel convex configuration within the Nano Series, distinguishing it from the 64-channel Nano C5 EXP. It uses a 2–5 MHz convex array with a 60 mm radius, supporting maximum scanning depth up to 30 cm—parameters oriented toward abdominal, obstetric, and deep-structure imaging in point-of-care settings. The transducer is IPX7-rated for dust and water resistance, weighs approximately 240 g, and operates for up to 5 hours on its internal battery with a 2.5-hour charge time from 8% to 90%.

The standard software package includes SynSight synthetic focused sonography, TAI tissue adaptive imaging, adaptive Doppler, frequency and spatial compounding, harmonic imaging, eSRI speckle reduction, spectrum enhancement, digital multi-beam forming, pan/digital zoom, full-screen zoom, auto trace, and eLearn. Optional licenses add Auto B-Line (lung assessment), eVocal (voice annotation), and eBladder (bladder volume measurement), while a needle guide bracket and MT-320 trolley are available for procedural and cart-based workflows.

The Nano C5 is built for point-of-care ultrasound (POCUS) users—emergency and critical care clinicians, primary care practitioners, obstetric and gynecological teams, and mobile or resource-limited care settings—who need immediate imaging capability without the footprint, cost, or power dependency of a cart-based system. EDAN’s own public communications describe the Nano Series being deployed to support basic prenatal care and early screening in resource-limited environments, with primary healthcare workers using the device for timely referral decisions. Availability, licensing terms, and cleared claims vary by market; confirm local registration and labeling before purchase.

Key Features & Benefits

Transducer-as-Device Architecture: No Console, No Cart

The Nano C5 separates acquisition from display. The convex transducer contains the full imaging front-end, and the EDAN Nano app on an iOS or Android device serves as the display, control interface, and storage environment. This eliminates the need for a dedicated ultrasound console, monitor, or cart at the point of care. The clinician holds the probe, views the image on a phone or tablet, and captures clips and stills directly within the app—supporting immediate imaging in emergency bays, examination rooms, ambulances, and home visits without transporting a cart.

FDA-Cleared for Ten Clinical Applications Across 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. This breadth means a single handheld probe can support focused assessment across multiple body regions and care locations, rather than being restricted to a single application or setting.

32-Physical-Channel Convex Array with SynSight Imaging

The Nano C5’s 32 physical channels drive a 2–5 MHz convex array with a 60 mm radius and maximum scanning depth of 30 cm. SynSight synthetic focused sonography generates coherent image data across the field of view, supported by TAI tissue adaptive imaging, eSRI speckle reduction, frequency and spatial compounding, and harmonic imaging. These processing tools are intended to support image consistency across patient body habitus and penetration for deeper abdominal and obstetric structures, within the constraints of a handheld convex probe.

IPX7 Waterproof and 5-Hour Battery for Field Use

The transducer is IPX7-rated for dust and water resistance, supporting cleaning and use in demanding clinical and field environments. At approximately 240 g, it is designed for single-hand scanning and 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 or emergency use.

Wireless or Wired Connectivity to iOS and Android

The Nano C5 communicates with the iOS or Android app via wired or wireless technology. DICOM, JPEG, and MP4 export is referenced in distributor documentation, alongside local storage and image sharing through Bluetooth, AirDrop, and third-party applications. This allows captured studies to be archived, shared for consultation, or transferred into practice management workflows where the infrastructure exists.

Optional Licenses for Targeted Clinical Workflows

The Nano C5 supports optional licenses for Auto B-Line (automated B-line detection for lung and pleural assessment), eVocal (voice annotation for hands-free documentation), and eBladder (bladder volume measurement)—each addressing a specific POCUS workflow without requiring a full system upgrade. A needle guide bracket (BGK-017) is available for in-plane needle visualization during ultrasound-guided procedures, and the MT-320 trolley provides a cart-based docking option for clinics that prefer a dedicated station.

Compact, Single-Hand Form Factor

The Nano C5 shares the Nano Series enclosure, approximately 158 × 81 × 29 mm and 240 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 where a cart-based system would be impractical.

Technical Specifications

Why Choose the EDAN Nano C5?