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510(k) K050925

DIGITAL RADIOGRAPHY SYSTEM RADSPEED SAFIRE by Shimadzu Corp. — Product Code MQB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 1, 2005
Date Received
April 13, 2005
Clearance Type
Abbreviated
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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