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510(k) K243226

Ultrasound Imaging System (LU700 Series); Ultrasound Imaging System (128 Series); Ultrasound Imaging System (LX Series) by Leltek, Inc. — Product Code IYN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 8, 2025
Date Received
October 8, 2024
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

Other clearances by Leltek, Inc.

  • K241161 — Ultrasound Imaging System (LK128L); Ultrasound Imaging System (LK128LH); Ultraso (September 11, 2024)
  • K222365 — Leltek Ultrasound Imaging System (Model: LU700 Series) (October 25, 2022)
  • K210432 — LELTEK Ultrasound Imaging System (Model: LU700 Series) (November 3, 2021)
  • K191235 — Leltek Ultrasound Imaging System (February 12, 2020)

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