iViewDose R1.0
FDA 510(k) K153011 · Elekta Limited
510(k) numberK153011
Submission
- Device name
- iViewDose R1.0
- Applicant
- Elekta Limited
Crawley, GB - Received
- October 14, 2015
- Decision date
- December 11, 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 iViewDose R1.0 cleared by the FDA?
iViewDose R1.0 (K153011) received a 510(k) decision of Substantially Equivalent on December 11, 2015, 58 days after the submission was received.
What is the product code of K153011?
The FDA product code is IYE – Accelerator, Linear, Medical, a Class II (moderate risk) device regulated under 21 CFR 892.5050.