G-SCAN-MODEL 9800020000, E-SCAN MODEL 9800010000 AND E-SCAN XQ-MODELS-9800010011/9800010005,9800010009/9800010004— 510(k) K060956
Substantially EquivalentEsaote, S.p.A.
FDA 510(k) clearance K060956 for G-SCAN-MODEL 9800020000, E-SCAN MODEL 9800010000 AND E-SCAN XQ-MODELS-9800010011/9800010005,9800010009/9800010004, Substantially Equivalent on 2006-05-04. Applicant: Esaote, S.p.A..
Clearance details
- Applicant
- Esaote, S.p.A.
- Product code
- Code LNH
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Carmel, IN, US
Adverse events under product code LNH
product code LNH- Death
- 11
- Injury
- 670
- Malfunction
- 1,460
- Other
- 2
- Total
- 2,143
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.