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510(k) K180161

Viz CTP by Viz. Ai, Inc. — Product Code LLZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 20, 2018
Date Received
January 19, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Image Processing, Radiological
Device Class
Class II
Regulation Number
892.2050
Review Panel
RA
Submission Type

Other clearances by Viz. Ai, Inc.

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  • DEN230003 — Viz HCM (August 3, 2023)
  • K223443 — Viz AAA (March 17, 2023)
  • K223042 — Viz LVO ContaCT (October 21, 2022)
  • K221100 — Viz RV/LV (August 29, 2022)
  • K220439 — Viz SDH (July 25, 2022)
  • K213319 — Viz ANEURYSM, Viz ANX (February 18, 2022)
  • K210209 — Viz ICH (March 23, 2021)
  • K193658 — Viz ICH (March 18, 2020)

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