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510(k) K041763

SHIMADZU MOBILE X-RAY SYSTEM MUX-100D SERIES by Shimadzu Corp. — Product Code IZL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 13, 2004
Date Received
June 30, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

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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  • K072006 — DAR-9400F (August 31, 2007)
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  • K062360 — BRANSIST SAFIRE (October 5, 2006)

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