FUJI COMPUTED RADIOGRAPHY SYSTEMS— 510(k) K944046
Substantially EquivalentFujifilm Medical System U.S.A., Inc.
FDA 510(k) clearance K944046 for FUJI COMPUTED RADIOGRAPHY SYSTEMS, Substantially Equivalent on 1995-05-11. Applicant: Fujifilm Medical System U.S.A., Inc.. Device class: 2.
Clearance details
- Applicant
- Fujifilm Medical System U.S.A., Inc.
- Product code
- Code IXW
- Device class
- Class 2
- Regulation
- 21 CFR 892.1900
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Stamford, CT, US
Recent devices under product code IXW
view allMore clearances from Fujifilm Medical System U.S.A., Inc.
view allRecalls naming K944046
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K944046.
Data sourced from openFDA. This site is unofficial and independent of the FDA.