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510(k) K123097

DOSE TRACKING SYSTEM MODEL XIDF-DTS801 by Toshiba America Medical Systems, In.C — Product Code JAA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 13, 2013
Date Received
October 2, 2012
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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  • K122109 — AQUILION ONE VISION, V4.90 (September 21, 2012)
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