MAGNETOM Avanto, MAGNETOM Verio with software syngo MR E11D— 510(k) K181613
Substantially EquivalentSiemens Medical Solutions USA, Inc.
FDA 510(k) clearance K181613 for MAGNETOM Avanto, MAGNETOM Verio with software syngo MR E11D, Substantially Equivalent on 2018-11-06. Applicant: Siemens Medical Solutions USA, Inc.. Device class: 2.
Clearance details
- Applicant
- Siemens Medical Solutions USA, Inc.
- Product code
- Code LNH
- Device class
- Class 2
- Regulation
- 21 CFR 892.1000
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Malvern, PA, US
Recent devices under product code LNH
view allMore clearances from Siemens Medical Solutions USA, Inc.
view allAdverse events under product code LNH
product code LNH- Death
- 11
- Injury
- 670
- Malfunction
- 1,460
- Other
- 2
- Total
- 2,143
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K181613
K-number listed on FDA's recall record- Z-2665-2025 — MAGNETOM Verio Dot. Model Number: 10684333.
- Z-2666-2025 — MAGNETOM Verio Dot Upgrade. Model Number: 10684334.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K181613.
Data sourced from openFDA. This site is unofficial and independent of the FDA.