ScandiDos Delta4 Phantom+
FDA 510(k) K151180 · Scandidos AB
510(k) numberK151180
Submission
- Device name
- ScandiDos Delta4 Phantom+
- Applicant
- Scandidos AB
Uppsala, SE - Received
- May 4, 2015
- Decision date
- August 19, 2015
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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|---|---|---|
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Questions and answers
When was ScandiDos Delta4 Phantom+ cleared by the FDA?
ScandiDos Delta4 Phantom+ (K151180) received a 510(k) decision of Substantially Equivalent on August 19, 2015, 107 days after the submission was received.
What is the product code of K151180?
The FDA product code is IYE – Accelerator, Linear, Medical, a Class II (moderate risk) device regulated under 21 CFR 892.5050.