MAGNETOM Avanto Fit; MAGNETOM Skyra Fit; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile
FDA 510(k) clearance K250443 · decided 2025-06-16
Clearance details
- K-number
- K250443
- Device name
- MAGNETOM Avanto Fit; MAGNETOM Skyra Fit; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile
- Applicant
- Siemens Healthcare GmbH
- Decision
- Substantially Equivalent
- Date received
- 2025-02-14
- Decision date
- 2025-06-16
- Days to decision
- 122 days
- Clearance type
- Traditional
- Product code
- LNH
- Device class
- 2
- Regulation number
- 892.1000
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Erlangen, DE
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| MAGNETOM Skyra fit. Model Number: 10849580. recall (Z-2661-2025) | Siemens Medical Solutions USA, Inc | 2025-09-30 |
| MAGNETOM Skyra Fit BioMatrix. Model Number: 11516217. recall (Z-2662-2025) | Siemens Medical Solutions USA, Inc | 2025-09-30 |