Nucletron Planning System
FDA 510(k) K911612 · Nucletron-Oldelft Corp.
510(k) numberK911612
Submission
- Device name
- Nucletron Planning System
- Applicant
- Nucletron-Oldelft Corp.
Columbia, MD, US - Received
- April 11, 1991
- Decision date
- June 13, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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Questions and answers
When was Nucletron Planning System cleared by the FDA?
Nucletron Planning System (K911612) received a 510(k) decision of Substantially Equivalent on June 13, 1991, 63 days after the submission was received.
What is the product code of K911612?
The FDA product code is IYE – Accelerator, Linear, Medical, a Class II (moderate risk) device regulated under 21 CFR 892.5050.