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510(k) K093640

DIGITAL X-RAY DETECTORS FAMILY KRC AND DIRA by Electron Jsco. — Product Code IXK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 29, 2011
Date Received
November 24, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Imaging, X-Ray, Electrostatic
Device Class
Class II
Regulation Number
892.1630
Review Panel
RA
Submission Type

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