FDA 510(k)

Delta4 Phantom+ MR (PMMA), Delta4 Phantom+ MR (PW)

K-Number: K183606 · 2019-04-08

Decision Date2019-04-08

Product CodeIYE

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

Delta4 Phantom+ MR (PMMA), Delta4 Phantom+ MR (PW) is a medical device manufactured by Scandidos AB. It received FDA 510(k) clearance on 2019-04-08 under approval number K183606. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Delta4 Phantom+ MR (PMMA), Delta4 Phantom+ MR (PW)?

Delta4 Phantom+ MR (PMMA), Delta4 Phantom+ MR (PW) is a medical device that received FDA 510(k) clearance on 2019-04-08. It is manufactured by Scandidos AB. The 510(k) number is K183606.

When was Delta4 Phantom+ MR (PMMA), Delta4 Phantom+ MR (PW) approved by the FDA?

Delta4 Phantom+ MR (PMMA), Delta4 Phantom+ MR (PW) received FDA 510(k) clearance on 2019-04-08, under approval number K183606.

What company makes Delta4 Phantom+ MR (PMMA), Delta4 Phantom+ MR (PW)?

Delta4 Phantom+ MR (PMMA), Delta4 Phantom+ MR (PW) is manufactured by Scandidos AB.

What is the FDA product code for Delta4 Phantom+ MR (PMMA), Delta4 Phantom+ MR (PW)?

The FDA product code for Delta4 Phantom+ MR (PMMA), Delta4 Phantom+ MR (PW) is IYE.

Other Devices by Scandidos AB

K151426ScandiDos Delta4 Discover, Alternative Trade Name: ScandiDos Delta4 Discover+ K223234Delta4 Insight

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.