Siemens Medical Solutions: FDA filings under this applicant name
FDA lists 15 510(k) clearances under the applicant name “Siemens Medical Solutions” (first 2003, latest 2025), across 8 product codes in 2 review panels. Median 510(k) review time under this name: 36 days. Since 2017 the median was 142 days, against 118 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Caduvo groups this applicant name under Siemens Healthineers, based on public ownership records.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 2 | 208 |
| 2023 | 2 | 41 |
| 2024 | 1 | 200 |
| 2025 | 2 | 136 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Siemens Medical Solutions took a median 142 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 118 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LLZ | System, Image Processing, Radiological | 4 | 4 |
| KPR | System, X-Ray, Stationary | 3 | 3 |
| OWB | Interventional Fluoroscopic X-Ray System | 3 | 3 |
| IZL | System, X-Ray, Mobile | 1 | 1 |
| JAK | System, X-Ray, Tomography, Computed | 1 | 1 |
| LNH | System, Nuclear Magnetic Resonance Imaging | 1 | 1 |
| MHX | Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | 1 | 1 |
| MOS | Coil, Magnetic Resonance, Specialty | 1 | 1 |
Review panels
- Radiology (14)
- Cardiovascular (1)
Most recent Siemens Medical Solutions 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K250738 | YSIO X.pree | KPR | 2025-07-31 | 142 |
| K250660 | LUMINOS Q.namix T; LUMINOS Q.namix R | OWB | 2025-07-14 | 131 |
| K233543 | YSIO X.pree | KPR | 2024-05-21 | 200 |
| K233532 | MULTIX Impact E | KPR | 2023-11-29 | 27 |
| K231577 | MOBILETT Impact | IZL | 2023-07-25 | 55 |
| K221281 | Multitom Rax | OWB | 2022-11-17 | 198 |
| K212212 | Multitom Rax with True2scale Body Scan Option | OWB | 2022-02-18 | 218 |
| K101749 | SYNGO TRUED SOFTWARE | LLZ | 2010-08-16 | 55 |
| K081018 | SYNGO DYNAMICS VERSION 7.0 | LLZ | 2008-04-25 | 15 |
| K071513 | INSPACE 4D SOFTWARE PACKAGE WITH EXTENDED FUNCTIONALITY | JAK | 2007-06-26 | 22 |
5 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Siemens Medical Solutions.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Siemens Medical Solutions (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 MOS)
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Siemens Medical Solutions USA, Inc. (784 510(k)s)
- Siemens Healthcare Diagnostics, Inc. (245 510(k)s)
- Siemens Corp. (67 510(k)s)
- Siemens Elema AB (63 510(k)s)
- Siemens Gammasonics, Inc. (53 510(k)s)
- Siemens Hearing Instruments, Inc. (42 510(k)s)
- Siemens Healthcare GmbH (32 510(k)s)
- Siemens Medi Cal Solutions, Inc. (32 510(k)s)
- Siemens AG Medical Solutions (31 510(k)s)
- Siemens Medical Systems, Inc. (25 510(k)s)
- Siemens Healthcare Diagnostics Products GmbH (23 510(k)s)
- Siemens AG (15 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Siemens Medical Solutions?
FDA lists 15 510(k) clearances under the applicant name “Siemens Medical Solutions” (first 2003, latest 2025), across 8 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Siemens Medical Solutions?
The median time from FDA receipt to decision across 510(k)s cleared under the name Siemens Medical Solutions is 36 days. Since 2017: 142 days, versus 118 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Siemens Medical Solutions?
The most frequent FDA product codes under this applicant name are LLZ (System, Image Processing, Radiological, 4); KPR (System, X-Ray, Stationary, 3); OWB (Interventional Fluoroscopic X-Ray System, 3).
Next steps
- See all 15 Siemens Medical Solutions clearances with predicates and recalls
- Run predicate analysis for product code LLZ, Siemens Medical Solutions's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.