MAGNETOM Lumina and MAGNETOM Vida Fit with syngo MR XA50A— 510(k) K220939
Substantially EquivalentSiemens Medical Solutions USA, Inc.
FDA 510(k) clearance K220939 for MAGNETOM Lumina and MAGNETOM Vida Fit with syngo MR XA50A, Substantially Equivalent on 2022-04-29. 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
- Special
- 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 K220939
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K220939.
Data sourced from openFDA. This site is unofficial and independent of the FDA.