TITAN ULTRASOUND SYSTEM, SONOSITE ILOOK 25 ULTRASOUND SYSTEM, 180PLUS ULTRASOUND SYSTEM, MODEL L03073, L02245, L02464— 510(k) K033367
Substantially EquivalentSonosite,Inc.
FDA 510(k) clearance K033367 for TITAN ULTRASOUND SYSTEM, SONOSITE ILOOK 25 ULTRASOUND SYSTEM, 180PLUS ULTRASOUND SYSTEM, MODEL L03073, L02245, L02464, Substantially Equivalent on 2003-11-05. Applicant: Sonosite,Inc..
Clearance details
- Applicant
- Sonosite,Inc.
- Product code
- Code IYN
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Bothell, WA, US
Adverse events under product code IYN
product code IYN- Death
- 25
- Injury
- 163
- Malfunction
- 1,538
- Other
- 4
- Total
- 1,730
Source: openFDA MAUDE database, through . 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.