K-number	K183606
Device name	Delta4 Phantom+ MR (PMMA), Delta4 Phantom+ MR (PW)
Applicant	Scandidos AB
Product code	IYE
Device class	Class II
Decision date	Apr 8, 2019
Decision	Substantially Equivalent
Regulation	892.5050

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Source

View the full FDA submission: accessdata.fda.gov

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

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