O-SCAN MR SYSTEM— 510(k) K092469
Substantially EquivalentEsaote, S.p.A.
FDA 510(k) clearance K092469 for O-SCAN MR SYSTEM, Substantially Equivalent on 2009-12-23. Applicant: Esaote, S.p.A.. Device class: 2.
Clearance details
- Applicant
- Esaote, S.p.A.
- Product code
- Product code LNH
- Device class
- Class 2
- Regulation
- 21 CFR 892.1000
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Carmel, IN, US
Recent devices under product code LNH
view allMore clearances from Esaote, S.p.A.
view allAdverse 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.