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510(k) K183388

JADE Mobile X-Ray by DRGEM Corporation — Product Code IZL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 5, 2019
Date Received
December 6, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, X-Ray, Mobile
Device Class
Class II
Regulation Number
892.1720
Review Panel
RA
Submission Type

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