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510(k) K111633

AQUILION LB MOVEMENT BASE KIT by Toshiba America Medical Systems, In.C — Product Code JAK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 25, 2011
Date Received
June 13, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, X-Ray, Tomography, Computed
Device Class
Class II
Regulation Number
892.1750
Review Panel
RA
Submission Type

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  • K122842 — RADREX-I, SW V4.00 MODEL DRAD-3000E (October 9, 2012)
  • K121076 — ULTRAEXTEND FX, ULTRASOUND WORKSTATION PACKAGE (October 9, 2012)
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