ARTISTE SOLUTION, SYS_VC10C, PHASE 2 UPDATE WITH THE SYNGO RT THERAPIST & RT ONCOLOGIST WORKSPACES, V4.3.1_MR1
FDA 510(k) clearance K142434 · decided 2014-11-21
Clearance details
- K-number
- K142434
- Device name
- ARTISTE SOLUTION, SYS_VC10C, PHASE 2 UPDATE WITH THE SYNGO RT THERAPIST & RT ONCOLOGIST WORKSPACES, V4.3.1_MR1
- Applicant
- Siemens Medical Solutions USA, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2014-08-29
- Decision date
- 2014-11-21
- Days to decision
- 84 days
- Clearance type
- Traditional
- Product code
- IYE
- Device class
- 2
- Regulation number
- 892.5050
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Martinez, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| ARTISTE, ONCOR and PRIMUS with syngo RT Therapist with software version 4.3.1 MR3. Materia recall (Z-0472-2023) | Siemens Medical Solutions USA, Inc | 2022-12-09 |
| ONCOR Avant Garde, ONCOR Impression Plus, ONCOR Expression, ONCOR Impression, PRIMUS HI, M recall (Z-0168-2016) | Siemens Medical Solutions USA, Inc | 2015-10-27 |
| Syngo RT Oncologist, an optional accessory to the linear accelerator system and permits lo recall (Z-0106-2016) | Siemens Medical Solutions USA, Inc | 2015-10-06 |
| Syngo RT Therapist: The intended use of the SIEMENS branded ARTISTE, ONCOR and PRIMUS fami recall (Z-1013-2015) | Siemens Medical Solutions USA, Inc | 2015-01-26 |
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 |