FUJIFILM DUAL ENERGY SUBTRACTION (DES) SOFTWARE OPTION— 510(k) K122454
Substantially EquivalentFujifilm Medical System U.S.A., Inc.
FDA 510(k) clearance K122454 for FUJIFILM DUAL ENERGY SUBTRACTION (DES) SOFTWARE OPTION, Substantially Equivalent on 2012-11-20. Applicant: Fujifilm Medical System U.S.A., Inc.. Device class: 2.
Clearance details
- Applicant
- Fujifilm Medical System U.S.A., Inc.
- Product code
- Code KPR
- Device class
- Class 2
- Regulation
- 21 CFR 892.1680
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Stamford, CT, US
Recent devices under product code KPR
view allMore clearances from Fujifilm Medical System U.S.A., Inc.
view allAdverse events under product code KPR
product code KPR- Other
- 6
- Total
- 6
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.