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510(k) K200622

Focus 43C detector, TRIMAX 43C detector by Iray Technology Taicang , Ltd. — Product Code MQB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 1, 2020
Date Received
March 9, 2020
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Solid State X-Ray Imager (Flat Panel/Digital Imager)
Device Class
Class II
Regulation Number
892.1680
Review Panel
RA
Submission Type

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