FUJIFILM DIAGNOSTIC ULTRASOUND SYSTEM FAZONE CB— 510(k) K110202
Substantially EquivalentFujifilm Medical System U.S.A., Inc.
FDA 510(k) clearance K110202 for FUJIFILM DIAGNOSTIC ULTRASOUND SYSTEM FAZONE CB, Substantially Equivalent on 2011-02-08. Applicant: Fujifilm Medical System U.S.A., Inc.. Device class: 2.
Clearance details
- Applicant
- Fujifilm Medical System U.S.A., Inc.
- Product code
- Code ITX
- Device class
- Class 2
- Regulation
- 21 CFR 892.1570
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Stamford, CT, US
Recent devices under product code ITX
view allMore clearances from Fujifilm Medical System U.S.A., Inc.
view allAdverse events under product code ITX
product code ITX- Death
- 6
- Injury
- 137
- Malfunction
- 2,036
- Total
- 2,179
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.