Siemens Healthineers AG: FDA clearances and approvals
Siemens Healthineers AG has 5 FDA 510(k) clearances (first 2025, latest 2026), across 4 product codes in 1 review panel. Median 510(k) review time: 137 days. Since 2017 its median was 137 days, against 124 days for all cleared 510(k)s in the same product codes.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2025 | 2 | 113 |
| 2026 | 3 | 137 |
Review time against the same product codes
Since 2017, Siemens Healthineers AG's cleared 510(k)s took a median 137 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 124 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| QIH | Automated Radiological Image Processing Software | 2 | 2 |
| LLZ | System, Image Processing, Radiological | 1 | 1 |
| LNH | System, Nuclear Magnetic Resonance Imaging | 1 | 1 |
| OUO | Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance | 1 | 1 |
Review panels
- Radiology (5)
Most recent Siemens Healthineers AG 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K260852 | MAGNETOM Flow.Elite;MAGNETOM Flow.Neo;MAGNETOM Flow.Rise;MAGNETOM Flow.Pure | LNH | 2026-07-31 | 137 |
| K253690 | LungMaps | QIH | 2026-06-15 | 206 |
| K253023 | BIOGRAPH One | OUO | 2026-01-15 | 118 |
| K253495 | syngo.MR Applications (VB80) | LLZ | 2025-11-20 | 23 |
| K251059 | Syngo Carbon Clinicals (VA41) | QIH | 2025-10-24 | 203 |
Recalls
openFDA lists no recalls under a recalling firm named Siemens Healthineers AG.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of Siemens Healthineers AG's product codes (a text match, not an official crosswalk):
- C8903 — Magnetic resonance imaging with contrast, breast; unilateral (via LNH)
- C8906 — Magnetic resonance imaging with contrast, breast; bilateral (via LNH)
- C8905 — Magnetic resonance imaging without contrast followed by with contrast, breast; unilateral (via LNH)
- C8908 — Magnetic resonance imaging without contrast followed by with contrast, breast; bilateral (via LNH)
- C8900 — Magnetic resonance angiography with contrast, abdomen (via LNH)
Frequently asked questions
How many FDA 510(k) clearances does Siemens Healthineers AG have?
Siemens Healthineers AG has 5 FDA 510(k) clearances (first 2025, latest 2026), across 4 product codes in 1 review panel.
How long does FDA take to clear Siemens Healthineers AG's 510(k)s?
The median time from FDA receipt to decision across Siemens Healthineers AG's cleared 510(k)s is 137 days. Since 2017: 137 days, versus 124 days for all cleared 510(k)s in the same product codes.
What devices does Siemens Healthineers AG make?
Its most frequent FDA product codes are QIH (Automated Radiological Image Processing Software, 2); LLZ (System, Image Processing, Radiological, 1); LNH (System, Nuclear Magnetic Resonance Imaging, 1).
Has Siemens Healthineers AG had device recalls?
openFDA lists no recalls under a recalling firm name matching Siemens Healthineers AG. Related entities may recall under other names.
Next steps
- See all 5 Siemens Healthineers AG clearances with predicates and recalls
- Run predicate analysis for product code QIH, Siemens Healthineers AG's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.