MAGNETOM AERA AND MAGNETOM SKYRA— 510(k) K111242
Substantially EquivalentSiemens Medical Solutions USA, Inc.
FDA 510(k) clearance K111242 for MAGNETOM AERA AND MAGNETOM SKYRA, Substantially Equivalent on 2011-11-23. 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
- Mavern, 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 K111242
K-number listed on FDA's recall record- Z-2342-2019 — MAGNETOM Aera magnetic resonance diagnostic devices Model # 10432914
- Z-2343-2019 — MAGNETOM Skyra magnetic resonance diagnostic devices Model # 10432915
- Z-1663-2014 — MAGNETOM Aera magnetic resonance system. Indicated for use as a magnetic resonance diagnostic device (MRDD) that produces transverse, sagittal, coronal and oblique cross sectional images, spectroscopic images and/or spectra, and that displays the internal structure and/or function of the head, body, or extremities.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K111242.
Data sourced from openFDA. This site is unofficial and independent of the FDA.