Home / 510(k) Clearances / K251106

510(k) K251106

Sonosite LX and Sonosite PX Ultrasound Systems by FUJIFILM Sonosite, Inc. — Product Code IYN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 29, 2025
Date Received
April 11, 2025
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 FUJIFILM Sonosite, Inc.

  • K260595 — Sonosite iLOOK Ultrasound System (March 10, 2026)
  • K253448 — Sonosite MT Ultrasound System (November 3, 2025)
  • K251830 — Sonosite LX Ultrasound System (July 10, 2025)
  • K233597 — Sonosite LX Ultrasound System (December 6, 2023)
  • K213763 — Sonosite PX Ultrasound System (December 27, 2021)
  • K202160 — Sonosite PX Ultrasound System, Sonosite SII Ultrasound System, Sonosite iViz Ult (September 1, 2020)
  • K200964 — Sonosite PX Ultrasound System (May 8, 2020)
  • K190476 — FUJIFILM Sonosite Vevo MD Imaging System (March 15, 2019)
  • K183235 — SonoSite SII Ultrasound System (February 7, 2019)
  • K180704 — SonoSite iViz Ultrasound System (April 13, 2018)

Other clearances for product code IYN

  • K260595 — Sonosite iLOOK Ultrasound System (March 10, 2026)
  • 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)