PINNACLE3 Radiation Therapy Planning System
FDA 510(k) K130992 · Philips Medical Systems (Cleveland), Inc.
510(k) numberK130992
Submission
- Device name
- PINNACLE3 Radiation Therapy Planning System
- Applicant
- Philips Medical Systems (Cleveland), Inc.
Austin, TX, US - Received
- April 10, 2013
- Decision date
- June 14, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was PINNACLE3 Radiation Therapy Planning System cleared by the FDA?
PINNACLE3 Radiation Therapy Planning System (K130992) received a 510(k) decision of Substantially Equivalent on June 14, 2013, 65 days after the submission was received.
What is the product code of K130992?
The FDA product code is IYE – Accelerator, Linear, Medical, a Class II (moderate risk) device regulated under 21 CFR 892.5050.