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510(k) K100067

MODEL VIAMO SSA-640A, VERSION 2.0 ULTRASOUND SYSTEM by Toshiba America Medical Systems, In.C — Product Code ITX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 28, 2010
Date Received
January 11, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Transducer, Ultrasonic, Diagnostic
Device Class
Class II
Regulation Number
892.1570
Review Panel
RA
Submission Type

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  • K121076 — ULTRAEXTEND FX, ULTRASOUND WORKSTATION PACKAGE (October 9, 2012)
  • K122842 — RADREX-I, SW V4.00 MODEL DRAD-3000E (October 9, 2012)
  • K122109 — AQUILION ONE VISION, V4.90 (September 21, 2012)

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