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510(k) K963888

C-ARM TABLE IVS-100 by Shimadzu Medical Systems — Product Code JAA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 18, 1996
Date Received
September 26, 1996
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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  • K071291 — ECHOVIEW / SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-1100 (January 9, 2008)
  • K061643 — ECHO VIEW/SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-1200PRO (July 27, 2006)
  • K061637 — ECHOVIEW/ SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-2200PRO (July 25, 2006)
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  • K052500 — DAR-8000F (October 17, 2005)
  • K052076 — DAR-8000I (September 2, 2005)
  • K050510 — ECHOVIEW/SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-1100 (April 1, 2005)

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