Healcerion Sonon 500L
Healcerion SONON 500L — Linear wireless handheld ultrasound
No annual fees. Every firmware and software upgrade included, forever.
FDA cleared (510(k)). Listed on the WHO Innovative Health Technology list. 40+ peer-reviewed publications. 6,000+ units deployed across 65 countries.
Specifications
| Manufacturer | Healcerion Co., Ltd. (South Korea) |
| Model | SONON 500L |
| Device type | Handheld wireless ultrasound, linear probe |
| Transducer | Linear |
| Frequency | 4-13 MHz |
| Maximum scan depth | 6 cm |
| Imaging modes | B-Mode, Color Flow, Pulsed Wave Doppler, M-Mode |
| Clinical applications | Musculoskeletal (MSK), vascular (incl. dialysis vascular access), small parts (breast, thyroid), thorax (pleural motion and fluid) |
| Weight | 280 g (with battery) |
| Dimensions | 55.7 x 177.5 x 38.6 mm |
| Water resistance | IPX7 (probe head) |
| Battery | Rechargeable Li-ion, 1200 mAh; 90+ minutes continuous scanning |
| Wireless | 5 GHz Wi-Fi (802.11n/ac) + Bluetooth LE 4.2 |
| Connectivity | DICOM, PACS and workflow server support |
| Compatible platforms | iOS, Android, Windows |
| Warranty | 12 months (device); 6 months (batteries, battery charger, power adapter) |
| In the box | SONON 500L ultrasound device, 2 rechargeable batteries, battery charger, power adapter (for battery charger), quick start guide |
| Subscription / software fees | None |
Regulatory & Compliance
| FDA 510(k) number | K212400 |
| FDA 510(k) decision date | 2022-04-22 |
| FDA decision | Substantially Equivalent |
| FDA product code | IYN |
| FDA regulation number | 21 CFR 892.1550 |
| FDA device class | Class II |
| FDA establishment registration | 3011648943 |
| UDI-DI / GTIN (FDA GUDID) | 08809489920029 |
| Prescription status | Rx only: for use by or on the order of a licensed healthcare professional |
| Standards | IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, ISO 10993 |
| Country of origin | South Korea (manufacturer certification, 2026-10-13) |
| Trade Agreements Act (TAA) | Compliant: designated country end product (FAR 52.225-5); manufacturer-certified 2026-10-13 |
Details
Rx only. Sold to licensed healthcare professionals and qualified facilities. Full specifications and FDA regulatory details are listed above.
Shipping & Returns
Ships free by FedEx 3-Day Express within the contiguous US, within 10 business days of payment clearing. Unwanted devices may be returned if we receive them within 10 calendar days of FedEx delivery (20% restocking fee). Damaged or incorrect items: no restocking fee.
Full details: Shipping Policy and Refund Policy.