Ximatron V
FDA 510(k) K810858 · Siemens Corp.
510(k) numberK810858
Submission
- Device name
- Ximatron V
- Applicant
- Siemens Corp.
Mchenry, IL, US - Received
- March 30, 1981
- Decision date
- May 13, 1981
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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Questions and answers
When was Ximatron V cleared by the FDA?
Ximatron V (K810858) received a 510(k) decision of Substantially Equivalent on May 13, 1981, 44 days after the submission was received.
What is the product code of K810858?
The FDA product code is KPQ – System, Simulation, Radiation Therapy, a Class II (moderate risk) device regulated under 21 CFR 892.5840.