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510(k) K240676

ULTIMUS Series Ultrasound Diagnostic System by Vinno Technology (Suzhou) Co.,Ltd — Product Code IYN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 16, 2024
Date Received
March 11, 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 Vinno Technology (Suzhou) Co.,Ltd

  • K230160 — VINNO G86,VINNO G86E,VINNO G65,VINNO G65P,VINNO G65E,VINNO G65D,VINNO M86, VINNO (June 23, 2023)
  • K223920 — VINNO G50, VINNO G55, VINNO M50, VINNO E30, VINNO X5, VINNO X6, VINNO X7, VINNO (June 17, 2023)
  • K223917 — VINNO E20, VINNO E10,VINNO E10P,VINNO E10E, VINNO X1,VINNO X1E,VINNO X1P, VINNO (June 17, 2023)
  • K221911 — VINNO 6PRO, VINNO 6EXP, VINNO 5PRO, VINNO 5EXP, VINNO 3, VINNO 3PRO, VINNO 3EXP (December 21, 2022)
  • K190120 — VINNO 8, VINNO 6, VINNO 5 (January 23, 2020)

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