ArcCHECK
FDA 510(k) K142617 · Sun Nuclear Corporation
510(k) numberK142617
Submission
- Device name
- ArcCHECK
- Applicant
- Sun Nuclear Corporation
Melbourne, FL, US - Received
- September 16, 2014
- Decision date
- November 20, 2015
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was ArcCHECK cleared by the FDA?
ArcCHECK (K142617) received a 510(k) decision of Substantially Equivalent on November 20, 2015, 430 days after the submission was received.
What is the product code of K142617?
The FDA product code is IYE – Accelerator, Linear, Medical, a Class II (moderate risk) device regulated under 21 CFR 892.5050.