SONOSITE NANOMAXX SERIES ULTRASOUND SYSTEM, SONOSITE MAXX SERIES ULTRASOUND SYSTEM— 510(k) K101757

Name: FDA 510(k) clearance K101757
Creator: U.S. Food and Drug Administration
Published: 2010-08-12

Substantially Equivalent

Sonosite,Inc.

FDA 510(k) clearance K101757 for SONOSITE NANOMAXX SERIES ULTRASOUND SYSTEM, SONOSITE MAXX SERIES ULTRASOUND SYSTEM, Substantially Equivalent on 2010-08-12. Applicant: Sonosite,Inc.. Device class: 2.

Clearance details

Applicant: Sonosite,Inc.
Product code: Code ITX
Device class: Class 2
Regulation: 21 CFR 892.1570
Advisory panel: Radiology
Date received: 2010-06-23
Decision date: 2010-08-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bothell, WA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code ITX

view all

K261170 — BA-004CC2026-08-12
K254143 — EM-TECH Passive Ultrasound Probe Strap2026-08-10
K260161 — SmartGuide Disposable Guides and Grids2026-07-30
K262474 — ND Needle Guidance System2026-07-27
K261014 — Accuro® 3S Needle Guide Kit2026-07-24

More clearances from Sonosite,Inc.

view all

K113156 — SONOSITE EDGE ULTRASOUND SYSTEM2011-11-15
K110645 — BIO Z CARDIO PROFILE HEMODYNAMIC MONITOR2011-06-03
K102390 — SONOSITE NANOMAXX SERIES ULTRASOUND SYSTEM2010-11-19
K093510 — LUMENVU CATHETER GUIDANCE SYSTEM2010-08-23
K092058 — SONOSITE NANOMAXX SERIES ULTRASOUND SYSTEM2009-10-02

Adverse events under product code ITX

product code ITX

Death: 6
Injury: 137
Malfunction: 2,036
Total: 2,179

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.