Siemens Healthcare GmbH: FDA clearances and approvals
Siemens Healthcare GmbH has 32 FDA 510(k) clearances (first 2016, latest 2026), across 9 product codes in 1 review panel. Median 510(k) review time: 108 days. Since 2017 its median was 112 days, against 119 days for all cleared 510(k)s in the same product codes.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2016 | 1 | 24 |
| 2017 | 4 | 40 |
| 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, Siemens Healthcare GmbH's cleared 510(k)s took a median 112 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 119 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 |
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | 1 | 1 |
| QDQ | Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer | 1 | 1 |
Review panels
- Radiology (32)
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 |
22 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 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 Healthcare GmbH'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 Healthcare GmbH have?
Siemens Healthcare GmbH has 32 FDA 510(k) clearances (first 2016, latest 2026), across 9 product codes in 1 review panel.
How long does FDA take to clear Siemens Healthcare GmbH's 510(k)s?
The median time from FDA receipt to decision across Siemens Healthcare GmbH's cleared 510(k)s is 108 days. Since 2017: 112 days, versus 119 days for all cleared 510(k)s in the same product codes.
What devices does Siemens Healthcare GmbH make?
Its most frequent FDA product codes are LLZ (System, Image Processing, Radiological, 14); QIH (Automated Radiological Image Processing Software, 5); JAK (System, X-Ray, Tomography, Computed, 3).
Has Siemens Healthcare GmbH had device recalls?
openFDA lists no recalls under a recalling firm name matching Siemens Healthcare GmbH. Related entities may recall under other names.
Next steps
- See all 32 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. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.