Name: Predicase
Price: 199 USD

K-number	K162190
Device name	Rotograph Prime (under trade mark Villa Sistemi Medicali), I-MAX (under trade mark Owandy Radiology)
Applicant	Villa Sistemi Medicali S.P.A.
Product code	MUH
Device class	Class II
Decision date	Jul 6, 2017
Decision	Substantially Equivalent
Regulation	872.1800

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Source

View the full FDA submission: accessdata.fda.gov

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Rotograph Prime (under trade mark Villa Sistemi Medicali), I-MAX (under trade mark Owandy Radiology)

Everything you need for a 510(k) submission. Nothing you don't.