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510(k) K210316

Mars 1417X Wireless Digital Flat Panel Detector by Iray Technology Taicang , Ltd. — Product Code MQB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 3, 2021
Date Received
February 3, 2021
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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