Total clearances
6
2024-07-26 → 2026-07-31
Name variants in FDA filings: Siemens Healthineers / Siemens Healthineers AG
Trend
Clearance cadence by quarter
Portfolio
Product codes worked
| Code |
Device name |
Class |
Specialty |
Clearances |
Most recent |
| QIH |
Automated Radiological Image Processing Software |
Class II |
Radiology |
2 |
2026-06-15 |
| LNH |
— |
— |
— |
1 |
2026-07-31 |
| OUO |
Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance |
Class II |
Radiology |
1 |
2026-01-15 |
| LLZ |
System, Image Processing, Radiological |
Class II |
Radiology |
1 |
2025-11-20 |
| KPS |
System, Tomography, Computed, Emission |
Class II |
Radiology |
1 |
2024-07-26 |
Filings
All 510(k) clearances (6)
| Date |
K-number |
Device |
Code |
Class |
Specialty |
| 2026-07-31 |
K260852 |
MAGNETOM Flow.Elite;MAGNETOM Flow.Neo;MAGNETOM Flow.Rise;MAGNETOM Flow.Pure |
LNH |
— |
— |
| 2026-06-15 |
K253690 |
LungMaps |
QIH |
Class II |
Radiology |
| 2026-01-15 |
K253023 |
BIOGRAPH One |
OUO |
Class II |
Radiology |
| 2025-11-20 |
K253495 |
syngo.MR Applications (VB80) |
LLZ |
Class II |
Radiology |
| 2025-10-24 |
K251059 |
Syngo Carbon Clinicals (VA41) |
QIH |
Class II |
Radiology |
| 2024-07-26 |
K241898 |
Symbia SPECT and SPECT/CT Systems |
KPS |
Class II |
Radiology |