We are pleased to announce that our breakthrough scoliosis assessment device, Scolioscan Air SCN201, has successfully obtained CE certification and 510(k) clearance from the US Food and Drug Administration (FDA).
With this CE certification and 510(k) clearance, Scolioscan Air SCN201 is now fully compliant with EU and FDA regulations and ready for market expansion across Europe, other CE-recognized regions and FDA-recognized regions. Combining advanced 3D ultrasound technology with radiation-free scoliosis evaluation, Scolioscan Air SCN201 offers a highly attractive solution for clinics, hospitals, and screening centers.