iDMS Data Management System
FDA 510(k) K161144 · Accuray Incorporated
510(k) numberK161144
Submission
- Device name
- iDMS Data Management System
- Applicant
- Accuray Incorporated
Sunnyvale, CA, US - Received
- April 22, 2016
- Decision date
- June 24, 2016
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was iDMS Data Management System cleared by the FDA?
iDMS Data Management System (K161144) received a 510(k) decision of Substantially Equivalent on June 24, 2016, 63 days after the submission was received.
What is the product code of K161144?
The FDA product code is IYE – Accelerator, Linear, Medical, a Class II (moderate risk) device regulated under 21 CFR 892.5050.