Rayautoplan 1.0: FDA 510(k) K083264

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK083264	Date22 Jan 2009Cleared	StatusActive

Official records

2 recalls · FDA

- Terminated Z-2444-2012 FDA Class II initiated 10 Oct 2011
This notice concerns behavior of the SharePlan that may be unexpected and not clearly described in the user manual. This behavior has not caused patient mistreatment or other incidents. However, the described user actions must be adhered to for best agreement between treatment plan evaluation and the clinical outcome of the delivered treatment. The behavior appears, when importing RFA-files (.asc)
- Terminated Z-2378-2012 FDA Class II initiated 30 May 2011
This field notice concerns two behaviors of the SharePlan (Multiple Fraction Groups and Depth Offset) that may be unexpected and are not clearly described in the user manual. None of these behaviors have caused patient mistreatment or other incidents. However, the described user actions must be adhered to for best agreement between treatment plan evaluation and the clinical outcome of the delivere

3 dated events

1 jurisdiction

United States — FDA 510(k) Active

510(k)

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Other devices filed under FDA product code MUJ (System, Planning, Radiation Therapy Treatment).