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510(k) K183191

6420 Ultrasound System by Esaote, S.P.A. — Product Code IYN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 4, 2018
Date Received
November 19, 2018
Clearance Type
Special
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

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  • K212419 — Magnifico Open, Magnifico MSK (February 4, 2022)
  • K212021 — 6430 MyLabX75, 6430 MyLab XPro75 (September 16, 2021)
  • K192157 — 6450 Ultrasound system (November 22, 2019)
  • K191072 — 7410 Ultrasound System (MyLabSigma) (June 10, 2019)

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  • K250959 — BioticsAI (December 22, 2025)
  • K252557 — Lumify Diagnostic Ultrasound System (December 22, 2025)
  • K252498 — Digital Color Doppler Ultrasound System (X11 Exp/X11 Elite/X11 Pro/X11 Plus/X11 (December 5, 2025)