Vision Rt, Ltd.
Vision Rt, Ltd. holds FDA 510(k) medical device clearances, first cleared 2018, most recent 2026, with 4 FDA device recalls on record.
Top product codes for Vision Rt, Ltd.
FDA recalls by Vision Rt, Ltd.
- Z-0998-2026 — The AlignRT InBore system contains six Class 1 lasers which enables the system s cameras to track the patient s position and movement.
- Z-0065-2019 — Integrated Gate Controller PCB (component of AlignRT Plus) Truebeam variant only. The AlignRT is a video-based three-dimensional (3D) surface imaging system which is used to image the skin surface of a patient in 3D before and during radiotherapy treatment. Part number: V000172
- Z-2667-2016 — AlignRT¿ Plus [private label-OSMS] K123371: The AlignRT Plus system is indicated for use to position and monitor patients relative to the prescribed treatment isocentre, and to withhold the beam automatically during radiation delivery.
- Z-2668-2016 — TrueBeam¿ Radiotherapy Delivery System and EDGE" Radiotherapy Delivery System, K140528. The TrueBeam and Edge Systems are intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body where radiation therapy is indicated for adults and pediatric patients.
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Vision Rt, Ltd.
Data sourced from openFDA. This site is unofficial and independent of the FDA.