Home / 510(k) Clearances / K984156

510(k) K984156

SHIMADZU WHOLE BODY X-RAY COMPUTED TOMOGRAPHY SCANNER SCT-7000TX W/FLURO OPTION by Shimadzu Medical Systems — Product Code JAK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 21, 1999
Date Received
November 19, 1998
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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  • K061637 — ECHOVIEW/ SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-2200PRO (July 25, 2006)
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  • K052076 — DAR-8000I (September 2, 2005)
  • K050510 — ECHOVIEW/SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-1100 (April 1, 2005)

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