MAGNETOM AERA; MAGNETOM SKYRA
FDA 510(k) clearance K101347 · decided 2010-10-01
Clearance details
- K-number
- K101347
- Device name
- MAGNETOM AERA; MAGNETOM SKYRA
- Applicant
- Siemens Medical Solutions USA, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2010-05-13
- Decision date
- 2010-10-01
- Days to decision
- 141 days
- Clearance type
- Traditional
- Product code
- LNH
- Device class
- 2
- Regulation number
- 892.1000
- 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 |
|---|---|---|
| BIOGRAPH One (DE). Model Number: 11689172. recall (Z-2655-2025) | Siemens Medical Solutions USA, Inc | 2025-09-30 |
| MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K1 recall (Z-2660-2025) | Siemens Medical Solutions USA, Inc | 2025-09-30 |
| MAGNETOM Aera/Skyra Systems, whole body magnetic resonance imaging systems, Model numbers recall (Z-1598-2016) | Siemens Medical Solutions USA, Inc | 2016-05-03 |
| Siemens Magnetom Skyra, Verio, Spectra and Biograph MMR Nuclear Magnetic Resonance Imaging recall (Z-2464-2012) | Siemens Medical Solutions USA, Inc | 2012-09-26 |
| Siemens MAGNETOM Aera/Skyra, model numbers 10432914 and 10432915. Nuclear magnetic resonan recall (Z-0940-2012) | Siemens Medical Solutions USA, Inc | 2012-02-02 |
| MAGNETOM Aera/Skyra System - Nuclear magnetic resonance imaging recall (Z-2979-2011) | Siemens Medical Solutions USA, Inc | 2011-08-10 |
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 |