Vision Rt, Ltd. - FDA 510(k) Cleared Devices

Vision Rt, Ltd. is a Radiology device manufacturer headquartered in London, UK. The company develops Surface Guided Radiation Therapy (SGRT) solutions that use 3D surface imaging to track patients and improve safety, effectiveness, and efficiency throughout the radiotherapy workflow. Over 3,000 systems are in active clinical use globally.

Vision RT has received 8 FDA 510(k) clearances from 8 total submissions since 2018, with no denied submissions. All submissions have focused on Radiology devices. The company's latest clearance was in 2026, confirming active regulatory engagement and ongoing product development.

The company's product portfolio spans the complete radiotherapy workflow: SimRT for 4D and breath-hold CT imaging, MapRT for treatment planning and beam clearance mapping, AlignRT for real-time patient tracking during treatment, and DoseRT for real-time dose visualization using Cherenkov imaging. These solutions serve diverse clinical applications including prostate, breast, head and neck, stereotactic radiosurgery, and proton therapy.

Explore the full list of cleared device names, product codes, and clearance dates in the 510(k) database.