LANTIS TREATSTATION
FDA 510(k) clearance K972275 · decided 1997-09-08
Clearance details
- K-number
- K972275
- Device name
- LANTIS TREATSTATION
- Applicant
- Siemens Medical Solutions USA, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1997-06-18
- Decision date
- 1997-09-08
- Days to decision
- 82 days
- Clearance type
- Traditional
- Product code
- IYE
- Device class
- 2
- Regulation number
- 892.5050
- 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 |
|---|---|---|
| Lantis 6.1 Commander, Model # 5493072 - Product Usage: Lantis Treatstation is to allow the recall (Z-2195-2019) | Siemens Medical Solutions USA, Inc | 2019-08-06 |
| Lantis 8.3 Commander, Model # 8148178 - Product Usage: Lantis Treatstation is to allow the recall (Z-2196-2019) | Siemens Medical Solutions USA, Inc | 2019-08-06 |
| Lantis Commander, Model # 4503178 - Product Usage: Lantis Treatstation is to allow the rad recall (Z-2197-2019) | Siemens Medical Solutions USA, Inc | 2019-08-06 |
| Siemens LANTIS Oncology Information System Servers; allows the radiation therapist to deli recall (Z-1282-2015) | Siemens Medical Solutions USA, Inc | 2015-03-16 |
| Siemens LANTIS System ; LANTIS Commander, 10 Users ; LANTIS 6.1 Commander ; LANTIS 8.3 Com recall (Z-1840-2014) | Siemens Medical Solutions USA, Inc | 2014-06-20 |
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 |