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510(k) K161119

SonoSite iViz Ultrasound System by FUJIFILM Sonosite, Inc. — Product Code IYN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 13, 2016
Date Received
April 20, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
System, Imaging, Pulsed Doppler, Ultrasonic
Device Class
Class II
Regulation Number
892.1550
Review Panel
RA
Submission Type

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  • K251830 — Sonosite LX Ultrasound System (July 10, 2025)
  • K233597 — Sonosite LX Ultrasound System (December 6, 2023)
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  • K202160 — Sonosite PX Ultrasound System, Sonosite SII Ultrasound System, Sonosite iViz Ult (September 1, 2020)
  • K200964 — Sonosite PX Ultrasound System (May 8, 2020)
  • K190476 — FUJIFILM Sonosite Vevo MD Imaging System (March 15, 2019)
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