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510(k) K243253

6600 Ultrasound System (MyLabA50); 6600 Ultrasound System (MyLabA70) by Esaote, S.P.A. — Product Code IYN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 18, 2025
Date Received
October 15, 2024
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 Esaote, S.P.A.

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  • K241671 — 6450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85) (May 16, 2025)
  • K241133 — Magnifico Open (100009900); Magnifico MSK ( 100009910) (June 26, 2024)
  • K230179 — 6440 MyLabX90 (November 29, 2023)
  • 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)
  • K190989 — 6400 Ultrasound System (MyLabX6, MyLabX7) (May 10, 2019)

Other clearances for product code IYN

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  • K253049 — Resona A10S, Resona A20 Pro, Resona A20T, Resona A20S, Resona A20W, Resona A20, (February 11, 2026)
  • K253597 — Aplio beyond and Aplio me Software V2.0 Diagnostic Ultrasound System (January 20, 2026)
  • K253370 — LOGIQ Totus (January 8, 2026)
  • K253366 — LOGIQ Fortis (January 7, 2026)
  • K252018 — HERA Z20 Diagnostic Ultrasound System; HERA Z20e Diagnostic Ultrasound System; H (January 5, 2026)
  • K251268 — Diagnostic Ultrasound System (Nano C5, Nano C5 EXP, Nano L12, and Nano L12 EXP) (December 23, 2025)
  • 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)