FUJI MEDICAL CR CONSOLE, MODEL FLASH IIP— 510(k) K041990
Substantially EquivalentFujifilm Medical System U.S.A., Inc.
FDA 510(k) clearance K041990 for FUJI MEDICAL CR CONSOLE, MODEL FLASH IIP, Substantially Equivalent on 2004-08-06. Applicant: Fujifilm Medical System U.S.A., Inc.. Device class: 2.
Clearance details
- Applicant
- Fujifilm Medical System U.S.A., Inc.
- Product code
- Code LLZ
- Device class
- Class 2
- Regulation
- 21 CFR 892.2050
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Stamford, CT, US
Recent devices under product code LLZ
view allMore clearances from Fujifilm Medical System U.S.A., Inc.
view allAdverse events under product code LLZ
product code LLZ- Death
- 13
- Total
- 13
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.