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510(k) K040870

SHIMADZU IMAGE AMPLIFIER, MODEL IA-16L/HS by Shimadzu Corp. — Product Code JAA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 17, 2004
Date Received
April 2, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, X-Ray, Fluoroscopic, Image-Intensified
Device Class
Class II
Regulation Number
892.1650
Review Panel
RA
Submission Type

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