SIREMOBIL ISO-C 3D
FDA 510(k) clearance K040347 · decided 2004-03-09
Clearance details
- K-number
- K040347
- Device name
- SIREMOBIL ISO-C 3D
- Applicant
- Siemens Medical Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2004-02-12
- Decision date
- 2004-03-09
- Days to decision
- 26 days
- Clearance type
- Traditional
- Product code
- OXO
- Device class
- 2
- Regulation number
- 892.1650
- 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 |
|---|---|---|
| Siremobil Iso-C Mobile X-Ray System recall (Z-0122-06) | Siemens Medical Solutions USA, Inc | 2005-11-02 |