Name: Predicase
Price: 199 USD

K-number	K201382
Device name	X-MIND prime 3D (under trademark Acteon), I-MAX 3D (under trademark Owandy Radiology)
Applicant	De Gotzen S.R.L.
Product code	OAS
Device class	Class II
Decision date	Nov 18, 2020
Decision	Substantially Equivalent
Regulation	892.1750

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Source

View the full FDA submission: accessdata.fda.gov

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X-MIND prime 3D (under trademark Acteon), I-MAX 3D (under trademark Owandy Radiology)

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