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510(k) K230220

NeuViz 128 Multi-Slice CT Scanner System by Neusoft Medical Systems Co., Ltd. — Product Code JAK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 11, 2023
Date Received
January 26, 2023
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

Other clearances by Neusoft Medical Systems Co., Ltd.

  • K171198 — NeuViz 16 Essence Multi-slice CT Scanner System (December 7, 2017)
  • K171201 — NeuViz Prime Multi-slice CT Scanner System (September 13, 2017)
  • 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)
  • K092237 — NSM-S15 SYSTEM (September 9, 2009)

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