Home / 510(k) Clearances / K010374

510(k) K010374

SONOSITE HAND-CARRIED ULTRASOUND SYSTEM by Sonosite,Inc. — Product Code IYN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 21, 2001
Date Received
February 7, 2001
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 Sonosite,Inc.

  • K113156 — SONOSITE EDGE ULTRASOUND SYSTEM (November 15, 2011)
  • K110645 — BIO Z CARDIO PROFILE HEMODYNAMIC MONITOR (June 3, 2011)
  • K102390 — SONOSITE NANOMAXX SERIES ULTRASOUND SYSTEM (November 19, 2010)
  • K093510 — LUMENVU CATHETER GUIDANCE SYSTEM (August 23, 2010)
  • K101757 — SONOSITE NANOMAXX SERIES ULTRASOUND SYSTEM, SONOSITE MAXX SERIES ULTRASOUND SYST (August 12, 2010)
  • K092058 — SONOSITE NANOMAXX SERIES ULTRASOUND SYSTEM (October 2, 2009)
  • K082098 — SONOSITE MAXX SERIES ULTRASOUND SYSTEM (August 25, 2008)
  • K071134 — SONOSITE MAXX SERIES DIAGNOSTIC ULTRASOUND SYSTEM (May 8, 2007)
  • K053069 — SONOSITE MICROMAXX DIAGNOSTIC ULTRASOUND SYSTEM (C3 SERIES) (November 16, 2005)
  • K052109 — SONOSITE HAND-CARRIED ULTRASOUND SYSTEM (C1 SERIES) (August 11, 2005)

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)