ARTIS icono (VE21) System
FDA 510(k) clearance K220432 · decided 2022-06-29
Clearance details
- K-number
- K220432
- Device name
- ARTIS icono (VE21) System
- Applicant
- Siemens Medical Solutions USA, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2022-02-15
- Decision date
- 2022-06-29
- Days to decision
- 134 days
- Clearance type
- Traditional
- Product code
- OWB
- Device class
- 2
- Regulation number
- 892.1650
- 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 is a family of dedicated angiography systems developed for single and biplane diagno recall (Z-2240-2024) | Siemens AG/Siemens Healthcare GmbH | 2024-07-02 |
| ARTIS icono biplane -Angiography systems developed for single and biplane diagnostic imagi recall (Z-2359-2023) | Siemens Medical Solutions USA, Inc | 2023-08-08 |
| ARTIS icono floor-Angiography systems developed for single and biplane diagnostic imaging recall (Z-2360-2023) | Siemens Medical Solutions USA, Inc | 2023-08-08 |
| Artis icono biplane- Model No. 11327600 Artis icono floor- Model No. 11327700 recall (Z-1647-2022) | Siemens Medical Solutions USA, Inc | 2022-08-26 |
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 |