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510(k) K202742

Dolphin/IQ, Dolphin/4D and Dolphin/MAX with Dolphin/XF robot accessory by Viasonix , Ltd. — Product Code IYN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 25, 2021
Date Received
September 18, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

Other clearances by Viasonix , Ltd.

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  • K170859 — Dolphin/IQ and Dolphin/4D (November 14, 2017)
  • K111416 — FALCON (July 15, 2011)

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