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510(k) K183235

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 7, 2019
Date Received
November 20, 2018
Clearance Type
Abbreviated
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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  • K190476 — FUJIFILM Sonosite Vevo MD Imaging System (March 15, 2019)
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