MAGNETOM Vida, MAGNETOM Sola, MAGNETOM Lumina, MAGNETOM Altea— 510(k) K203443
Substantially EquivalentSiemens Medical Solutions USA, Inc.
FDA 510(k) clearance K203443 for MAGNETOM Vida, MAGNETOM Sola, MAGNETOM Lumina, MAGNETOM Altea, Substantially Equivalent on 2021-03-31. 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 K203443
K-number listed on FDA's recall record- Z-2658-2025 — MAGNETOM Lumina (DE). Model Number: 11344916.
- Z-2447-2021 — MR MAGNETOM Systems with RT Image Suite with syngo MR VA20A, VA30A and VA31A with license SW-Key CT_RT_IMA_SUITE_SYNTHETIC_CT Material Numbers: 11060815
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K203443.
Data sourced from openFDA. This site is unofficial and independent of the FDA.