FUJI COMPUTED RADIOGRAPHY OD-F623 OPTICAL-DISK— 510(k) K921112
Substantially EquivalentFujifilm Medical System U.S.A., Inc.
FDA 510(k) clearance K921112 for FUJI COMPUTED RADIOGRAPHY OD-F623 OPTICAL-DISK, Substantially Equivalent on 1993-04-27. 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.