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510(k) K121792

NEUVIZ 64 MULTI-SLICE CT SCANNER SYSTEM by Neusoft Medical Systems Co., Ltd. — Product Code JAK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 16, 2012
Date Received
June 28, 2012
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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  • K092742 — NEUVIZ 16 MULTI-SLICE CT SCANNER SYSTEM (September 22, 2009)
  • K092237 — NSM-S15 SYSTEM (September 9, 2009)

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