ARTIS ZEE / ZEEGOS WITH SW VC14
FDA 510(k) clearance K090745 · decided 2009-06-18
Clearance details
- K-number
- K090745
- Device name
- ARTIS ZEE / ZEEGOS WITH SW VC14
- Applicant
- Siemens Medical Solutions USA, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2009-03-20
- Decision date
- 2009-06-18
- Days to decision
- 90 days
- Clearance type
- Traditional
- Product code
- IZI
- Device class
- 2
- Regulation number
- 892.1600
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Malvern, PA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Artis zee systems x-ray, angiographic system recall (Z-0172-2014) | Siemens Medical Solutions USA, Inc | 2013-11-14 |
| Siemens AXIOM Artis zeego x-ray, angiographic system recall (Z-1945-2013) | Siemens Medical Solutions USA, Inc | 2013-08-09 |
| ARTIS zee and zeego x-ray, angiographic system with Software Artis VC20x/VC21A that have P recall (Z-1782-2013) | Siemens Medical Solutions USA, Inc | 2013-07-22 |
| Siemens AXIOM Artis zee/zeego systems equipped with generator A100 Plus Product Usage: Ang recall (Z-1750-2013) | Siemens Medical Solutions USA, Inc | 2013-07-17 |
| Artis Systems with Software Artis VC20x/VC21A/VD10x that have a DSA license installed. Ang recall (Z-0997-2013) | Siemens Medical Solutions USA, Inc | 2013-03-26 |
| Siemens Axiom Artis zeego systems with software version VC14, VC20 and VC21 in conjunction recall (Z-0992-2013) | Siemens Medical Solutions USA, Inc | 2013-03-25 |
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 |