Siemens AG Medical Solutions: FDA clearances and approvals
Siemens AG Medical Solutions has 31 FDA 510(k) clearances (first 2003, latest 2015), across 5 product codes in 1 review panel. Median 510(k) review time: 25 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 71 |
| 2013 | 1 | 29 |
| 2014 | 1 | 268 |
| 2015 | 1 | 187 |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LLZ | System, Image Processing, Radiological | 17 | 17 |
| JAK | System, X-Ray, Tomography, Computed | 10 | 10 |
| OEB | Lung Computed Tomography System, Computer-Aided Detection | 2 | 2 |
| MOS | Coil, Magnetic Resonance, Specialty | 1 | 1 |
| NWE | Colon Computed Tomography System, Computer Aided Detection | 1 | 1 |
Review panels
- Radiology (31)
Most recent Siemens AG Medical Solutions 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K143196 | syngo.CT Lung CAD | OEB | 2015-05-12 | 187 |
| K130998 | SYNGO.VIA WEB VIEWER | LLZ | 2014-01-03 | 268 |
| K123920 | SYNGO.VIA | LLZ | 2013-01-18 | 29 |
| K120331 | SYNGO CT DYNAMIC ANGIO | JAK | 2012-04-13 | 71 |
| K111079 | SYNGO.VIA WEB VIEWER | LLZ | 2011-05-13 | 25 |
| K101666 | SYNGO. PLAZA VA20A | LLZ | 2010-08-10 | 57 |
| K100637 | SYNGO.CT CORONARY ANALYSIS | JAK | 2010-05-26 | 82 |
| K093612 | SYNGO.PLAZA | LLZ | 2010-03-04 | 101 |
| K092067 | ABVS WORKPLACE | LLZ | 2009-09-18 | 71 |
| K092519 | SYNGO.X | LLZ | 2009-08-27 | 9 |
21 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Siemens AG Medical Solutions.
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 AG Medical Solutions's product codes (a text match, not an official crosswalk):
- C8900 — Magnetic resonance angiography with contrast, abdomen (via MOS)
- C8901 — Magnetic resonance angiography without contrast, abdomen (via MOS)
- C8918 — Magnetic resonance angiography with contrast, pelvis (via MOS)
- C8919 — Magnetic resonance angiography without contrast, pelvis (via MOS)
- C8902 — Magnetic resonance angiography without contrast followed by with contrast, abdomen (via MOS)
Frequently asked questions
How many FDA 510(k) clearances does Siemens AG Medical Solutions have?
Siemens AG Medical Solutions has 31 FDA 510(k) clearances (first 2003, latest 2015), across 5 product codes in 1 review panel.
How long does FDA take to clear Siemens AG Medical Solutions's 510(k)s?
The median time from FDA receipt to decision across Siemens AG Medical Solutions's cleared 510(k)s is 25 days.
What devices does Siemens AG Medical Solutions make?
Its most frequent FDA product codes are LLZ (System, Image Processing, Radiological, 17); JAK (System, X-Ray, Tomography, Computed, 10); OEB (Lung Computed Tomography System, Computer-Aided Detection, 2).
Has Siemens AG Medical Solutions had device recalls?
openFDA lists no recalls under a recalling firm name matching Siemens AG Medical Solutions. Related entities may recall under other names.
Next steps
- See all 31 Siemens AG Medical Solutions clearances with predicates and recalls
- Run predicate analysis for product code LLZ, Siemens AG Medical Solutions'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.