Healium Intelliscan Corporation · Class II · Cleared May 5, 2026
| K-number | K261132 |
| Device name | Healium Intelliscan LX192LC |
| Applicant | Healium Intelliscan Corporation |
| Product code | IYN |
| Device class | Class II |
| Decision date | May 5, 2026 |
| Decision | Substantially Equivalent |
| Regulation | 892.1550 |
The Healium Intelliscan LX192LC is a portable, handheld ultrasound imaging system with dual-headed transducers (linear and convex) that runs as a mobile app on tablets or smartphones via Wi-Fi connectivity. It is intended for diagnostic ultrasound imaging and fluid flow analysis across multiple clinical applications including fetal, abdominal, cardiac, vascular, musculoskeletal, and other examinations, operated by qualified healthcare professionals in clinical settings.
The device is identical to the predicate in design, materials, energy source (rechargeable battery), software, and performance. It features the same imaging modes (B, M, PWD, Color Doppler, Power Doppler, and combined modes), principle of operation (ultrasonic transmission/reception with beamforming), and is manufactured by the same contract manufacturer (Leltek Inc.).
The device complies with multiple internationally recognized standards including IEC 60601 series (medical electrical equipment safety), ISO 13485 (quality management systems), IEC 62304 (medical device software lifecycle processes), ISO 10993 series (biocompatibility), and ISO 14971 (risk management), among others listed in the performance data table.
View the full FDA submission: accessdata.fda.gov