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510(k) K080540

NEUSOFT SPIRAL CT SCANNER SYSTEM, MODEL NEUVIZ VERSION 2.0 by Neusoft Medical Systems Co., Ltd. — Product Code JAK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 13, 2008
Date Received
February 27, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

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

Other clearances by Neusoft Medical Systems Co., Ltd.

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  • K151383 — NeuViz 128 Multi-slice CT Scanner System (November 4, 2015)
  • K151403 — Positron Emission Tomography (PET) and Computed Tomography (CT) System, Positron (November 2, 2015)
  • K133373 — CLEARVIEW (December 3, 2014)
  • K121792 — NEUVIZ 64 MULTI-SLICE CT SCANNER SYSTEM (November 16, 2012)
  • K110077 — NEUCOLONCARE (January 28, 2011)
  • K102435 — BEYONDIMAGE WORKSTATION (October 15, 2010)
  • K092742 — NEUVIZ 16 MULTI-SLICE CT SCANNER SYSTEM (September 22, 2009)

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