MOBILETT MIRA
FDA 510(k) clearance K111912 · decided 2011-09-19
Clearance details
- K-number
- K111912
- Device name
- MOBILETT MIRA
- Applicant
- Siemens Medical Solutions USA, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2011-07-05
- Decision date
- 2011-09-19
- Days to decision
- 76 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 |
|---|---|---|
| Mobilett Mira wireless (VA20) mobile x-ray system(s) recall (Z-0223-2024) | Siemens Medical Solutions USA, Inc | 2023-11-14 |
| Mobiletta Mira Mobile X-ray System recall (Z-1875-2013) | Siemens Medical Solutions USA, Inc | 2013-08-05 |
| Siemens Mobilette Mira, intended use as Mobile x-ray system. recall (Z-0480-2013) | Siemens Medical Solutions USA, Inc | 2012-12-06 |
| Siemens Mobilett Mira mobile x-ray system Product Usage: Mobile x-ray system recall (Z-2367-2012) | Siemens Medical Solutions USA, Inc | 2012-09-11 |
| Siemens Mobilett Mira. Mobile X-Ray System. recall (Z-2322-2012) | Siemens Medical Solutions USA, Inc | 2012-09-06 |
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| MAMMOMAT B.brilliant with Tomosynthesis Option (P140011/S008) | Siemens Medical Solutions USA, Inc. | 2024-09-23 |
| MAMMOMAT Revelation with Tomosynthesis Option System (P140011/S007) | Siemens Medical Solutions USA, Inc. | 2020-08-21 |
| MAMMOMAT Revelation with Tomosynthesis Option (P140011/S006) | Siemens Medical Solutions USA, Inc. | 2019-12-10 |
| Mammomat Inspiration with Tomosynthesis Option / Mammomat Revelation with Tomosynthesis Option (P140011/S005) | Siemens Medical Solutions USA, Inc. | 2017-09-29 |
| MAMMOMAT INSPIRATION WITH TOMOSYNTHESIS OPTION (P140011/S003) | Siemens Medical Solutions USA, Inc. | 2017-03-23 |
| MAMMOMAT INSPIRATION WITH TOMOSYNTHESIS OPTION (P140011/S001) | Siemens Medical Solutions USA, Inc. | 2016-05-12 |
| MAMMOMAT INSPIRATION TOMOSYNTHESIS OPTION (P140011/S002) | Siemens Medical Solutions USA, Inc. | 2016-01-13 |
| MAMMOMAT INSPIRATION WITH TOMOSYNTHESIS OPTION (P140011) | Siemens Medical Solutions USA, Inc. | 2015-04-21 |