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510(k) K080701

SHIMADZU MOBILE X-RAY SYSTEM MOBILEDART EVOLUTION by Shimadzu Corp. — Product Code IZL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 14, 2008
Date Received
March 11, 2008
Clearance Type
Abbreviated
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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