MAGNETOM AVANTO MR SYSTEM
FDA 510(k) clearance K032428 · decided 2003-10-16
Clearance details
- K-number
- K032428
- Device name
- MAGNETOM AVANTO MR SYSTEM
- Applicant
- Siemens Medical Solutions USA, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2003-07-29
- Decision date
- 2003-10-16
- Days to decision
- 79 days
- Clearance type
- Traditional
- Product code
- LNH
- Device class
- 2
- Regulation number
- 892.1000
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Mavern, PA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| MAGNETOM systems, magnetic resonance diagnostic devices (MRDD). recall (Z-0467-2016) | Siemens Medical Solutions USA, Inc | 2015-12-22 |
| MAGNETOM Avanto, Espree, Trio A Tim System. Nuclear magnetic resonance imaging. recall (Z-2021-2011) | Siemens Medical Solutions USA, Inc | 2011-04-18 |
| Magnetom Avanto. Magnetic Resonance Imaging System. Model number 7391167 recall (Z-1528-05) | Siemens Medical Solutions USA, Inc | 2005-09-09 |
| Magnetom Avanto MRI System, Model 7391167 recall (Z-1395-04) | Siemens Medical Solutions USA, Inc | 2004-08-24 |
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 |