SOFTWARE SYNGO MR D13A FOR THE MAGNETOM SYSTEMS AERA/SKYRA/AVANTO/VERIO
FDA 510(k) clearance K121434 · decided 2012-11-05
Clearance details
- K-number
- K121434
- Device name
- SOFTWARE SYNGO MR D13A FOR THE MAGNETOM SYSTEMS AERA/SKYRA/AVANTO/VERIO
- Applicant
- Siemens Medi Cal Solutions, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2012-05-14
- Decision date
- 2012-11-05
- Days to decision
- 175 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 |
|---|---|---|
| MAGNETOM Verio Dot. Model Number: 10684333. recall (Z-2665-2025) | Siemens Medical Solutions USA, Inc | 2025-09-30 |
| MAGNETOM Verio Dot Upgrade. Model Number: 10684334. recall (Z-2666-2025) | Siemens Medical Solutions USA, Inc | 2025-09-30 |
| MAGNETOM systems Aera/Skyra/Avanto/Verio with software syngo MR D13A ; indicated for use a recall (Z-1308-2015) | Siemens Medical Solutions USA, Inc | 2015-03-20 |