Siemens Healthcare GmbH: FDA filings under this applicant name
FDA lists 31 510(k) clearances under the applicant name “Siemens Healthcare GmbH” (first 2016, latest 2026), across 8 product codes in 1 review panel. Median 510(k) review time under this name: 112 days. Since 2017 the median was 116 days, against 127 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 |
|---|---|---|
| 2016 | 1 | 24 |
| 2017 | 3 | 52 |
| 2018 | 2 | 37 |
| 2019 | 1 | 27 |
| 2020 | 1 | 28 |
| 2021 | 1 | 146 |
| 2022 | 4 | 178 |
| 2023 | 5 | 77 |
| 2024 | 3 | 120 |
| 2025 | 6 | 160 |
| 2026 | 4 | 190 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Siemens Healthcare GmbH took a median 116 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 127 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LLZ | System, Image Processing, Radiological | 14 | 14 |
| QIH | Automated Radiological Image Processing Software | 5 | 5 |
| JAK | System, X-Ray, Tomography, Computed | 3 | 3 |
| LNH | System, Nuclear Magnetic Resonance Imaging | 2 | 2 |
| OEB | Lung Computed Tomography System, Computer-Aided Detection | 2 | 2 |
| QKB | Radiological Image Processing Software For Radiation Therapy | 2 | 2 |
| QTZ | Radiological Image Processing Software For Ablation Therapy Planning And Evaluation | 2 | 2 |
| QDQ | Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer | 1 | 1 |
Review panels
- Radiology (31)
Most recent Siemens Healthcare GmbH 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K253264 | myAblation Guide (VC10A) | QTZ | 2026-06-16 | 260 |
| K253689 | syngo Dynamics (VA41F) | QIH | 2026-04-10 | 140 |
| K252548 | AI-Rad Companion Organs RT | QKB | 2026-04-10 | 240 |
| K253057 | AI-Rad Companion Brain MR | QIH | 2026-01-22 | 122 |
| K252838 | MAGNETOM Sola; MAGNETOM Altea; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile; MAGNETOM Vida; MAGNETOM Lumina; MAGNETOM Vida Fit; MAGNETOM Flow.Elite; MAGNETOM Flow.Neo; MAGNETOM Flow.Rise | LNH | 2025-12-19 | 105 |
| K252608 | AI-Rad Companion Prostate MR | LLZ | 2025-09-09 | 22 |
| K250443 | MAGNETOM Avanto Fit; MAGNETOM Skyra Fit; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile | LNH | 2025-06-16 | 122 |
| K242551 | syngo Dynamics (Version VA41D) | QIH | 2025-04-03 | 219 |
| K242745 | AI-Rad Companion Organs RT | QKB | 2025-03-27 | 197 |
| K241770 | Prostate MR AI (VA10A) | QDQ | 2025-03-05 | 258 |
21 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Siemens Healthcare GmbH.
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 Healthcare GmbH (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)
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 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 (18 510(k)s)
- Siemens AG (15 510(k)s)
- Siemens Medical Electronics (15 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Siemens Healthcare GmbH?
FDA lists 31 510(k) clearances under the applicant name “Siemens Healthcare GmbH” (first 2016, latest 2026), across 8 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Siemens Healthcare GmbH?
The median time from FDA receipt to decision across 510(k)s cleared under the name Siemens Healthcare GmbH is 112 days. Since 2017: 116 days, versus 127 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Siemens Healthcare GmbH?
The most frequent FDA product codes under this applicant name are LLZ (System, Image Processing, Radiological, 14); QIH (Automated Radiological Image Processing Software, 5); JAK (System, X-Ray, Tomography, Computed, 3).
Next steps
- See all 31 Siemens Healthcare GmbH clearances with predicates and recalls
- Run predicate analysis for product code LLZ, Siemens Healthcare GmbH'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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.