FCR GO PORTABLE DIGITAL X-RAY SYSTEM— 510(k) K080945
Substantially EquivalentFujifilm Medical Systems U.S.A, Inc.
FDA 510(k) clearance K080945 for FCR GO PORTABLE DIGITAL X-RAY SYSTEM, Substantially Equivalent on 2008-04-18. Applicant: Fujifilm Medical Systems U.S.A, Inc.. Device class: 2.
Clearance details
- Applicant
- Fujifilm Medical Systems U.S.A, Inc.
- Product code
- Code IZL
- Device class
- Class 2
- Regulation
- 21 CFR 892.1720
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Stamford, CT, US
Recent devices under product code IZL
view allMore clearances from Fujifilm Medical Systems U.S.A, Inc.
view allAdverse events under product code IZL
product code IZL- Other
- 3
- Total
- 3
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.