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510(k) K213763

Sonosite PX Ultrasound System by FUJIFILM Sonosite, Inc. — Product Code IYN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 27, 2021
Date Received
December 1, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

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.

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  • K251106 — Sonosite LX and Sonosite PX Ultrasound Systems (August 29, 2025)
  • K251830 — Sonosite LX Ultrasound System (July 10, 2025)
  • K233597 — Sonosite LX Ultrasound System (December 6, 2023)
  • 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)

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