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510(k) K101757

SONOSITE NANOMAXX SERIES ULTRASOUND SYSTEM, SONOSITE MAXX SERIES ULTRASOUND SYSTEM by Sonosite,Inc. — Product Code ITX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 12, 2010
Date Received
June 23, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Transducer, Ultrasonic, Diagnostic
Device Class
Class II
Regulation Number
892.1570
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)
  • 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)
  • K043559 — SONOSITE HIGH-RESOLUTION DIAGNOSTIC ULTRASOUND SYSTEM (C3 SERIES) (January 12, 2005)

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  • K233109 — TP Pivot Pro™ Needle Guide (December 22, 2023)
  • K231666 — Endoscopic Ultrasonic Probe (P2612S-L); Endoscopic Ultrasonic Probe (P2620S-L) (December 13, 2023)
  • K231783 — VitroPRO (November 14, 2023)