550 TXT TREATMENT TABLE
FDA 510(k) clearance K050422 · decided 2005-03-18
Clearance details
- K-number
- K050422
- Device name
- 550 TXT TREATMENT TABLE
- Applicant
- Siemens Medical Solutions USA, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2005-02-18
- Decision date
- 2005-03-18
- Days to decision
- 28 days
- Clearance type
- Special
- Product code
- JAI
- Device class
- 2
- Regulation number
- 892.5770
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Concord, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| PRIMUS, ONCOR, ARTISTE Linac systems with component 550 TxT Treatment Table. TT-A, TT-D, T recall (Z-0787-2014) | Siemens Medical Solutions USA, Inc | 2014-01-17 |
| Siemens brand 550 TxT Patient Treatment Table, part number 7346534; Product is manufacture recall (Z-2023-2011) | Siemens Medical Solutions USA, Inc | 2011-04-19 |
| Siemens brand 550 TxT Patient Table, Part No. 7346534, Distributed by and/or Manufactured recall (Z-0166-2011) | Siemens Medical Solutions USA, Inc | 2010-10-28 |
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 |