FDR IMAGE STITCHING OPTION— 510(k) K101686
Substantially EquivalentFujifilm Medical System U.S.A., Inc.
FDA 510(k) clearance K101686 for FDR IMAGE STITCHING OPTION, Substantially Equivalent on 2010-10-29. Applicant: Fujifilm Medical System U.S.A., Inc..
Clearance details
- Applicant
- Fujifilm Medical System U.S.A., Inc.
- Product code
- Code KPR
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Stamford, CT, US
Adverse 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.