MOBILETTE XP AND MOBILETT XPHYBRID
FDA 510(k) clearance K033238 · decided 2003-11-14
Clearance details
- K-number
- K033238
- Device name
- MOBILETTE XP AND MOBILETT XPHYBRID
- Applicant
- Siemens Medical Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2003-10-06
- Decision date
- 2003-11-14
- Days to decision
- 39 days
- Clearance type
- Special
- Product code
- IZL
- Device class
- 2
- Regulation number
- 892.1720
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Mavern, PA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Siemens Mobilett XP Digital Mobile X-ray System Product Usage: The Mobilett XP and Mobilet recall (Z-1985-2014) | Siemens Medical Solutions USA, Inc | 2014-07-02 |
| Mobilett XP Hybrid/Digital/CR Intended use: mobile x-ray system recall (Z-0718-2011) | Siemens Medical Solutions USA, Inc | 2010-12-17 |
| Mobilett XP and Mobilett XP Hybrid, Mobile radiology device System, x-ray, mobile recall (Z-0171-2011) | Siemens Medical Solutions USA, Inc | 2010-11-01 |
| Mobilett XP, mobile X-ray system, Model number 1818454 recall (Z-0749-2007) | Siemens Medical Solutions USA, Inc | 2007-04-19 |