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510(k) K203374

X-MIND prime (under trade mark Acteon), I-MAX (under trade mark Owandy Radiology) by De Götzen S.R.L. — Product Code MUH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 5, 2021
Date Received
November 16, 2020
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, X-Ray, Extraoral Source, Digital
Device Class
Class II
Regulation Number
872.1800
Review Panel
RA
Submission Type

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