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510(k) K230811

Digital Intraoral X-Ray Sensor by Iray Imaging Technology (Haining) Limited — Product Code MUH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 21, 2023
Date Received
March 24, 2023
Clearance Type
Special
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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