Siemens Medical Solution USA, Inc.: FDA clearances and approvals
Siemens Medical Solution USA, Inc. has 8 FDA 510(k) clearances (first 2017, latest 2022), across 4 product codes in 1 review panel. Median 510(k) review time: 85 days. Since 2017 its median was 85 days, against 112 days for all cleared 510(k)s in the same product codes.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2017 | 2 | 96 |
| 2018 | 1 | 77 |
| 2019 | 2 | 118 |
| 2020 | 2 | 73 |
| 2021 | 0 | — |
| 2022 | 1 | 182 |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Siemens Medical Solution USA, Inc.'s cleared 510(k)s took a median 85 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 112 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LLZ | System, Image Processing, Radiological | 3 | 3 |
| OWB | Interventional Fluoroscopic X-Ray System | 3 | 3 |
| KPS | System, Tomography, Computed, Emission | 1 | 1 |
| LNH | System, Nuclear Magnetic Resonance Imaging | 1 | 1 |
Review panels
- Radiology (8)
Most recent Siemens Medical Solution USA, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K220433 | syngo Application Software (VE21) | LLZ | 2022-08-16 | 182 |
| K201156 | ARTIS pheno (VE2) | OWB | 2020-06-29 | 60 |
| K193178 | Biograph Horizon | KPS | 2020-02-12 | 86 |
| K190780 | syngo Application Software | LLZ | 2019-09-12 | 169 |
| K190757 | MAGNETOM Avanto Fit | LNH | 2019-05-31 | 67 |
| K181407 | Artis zee/zeego & Artis Q/Q.zen | OWB | 2018-08-15 | 77 |
| K163286 | ARTIS pheno | OWB | 2017-03-09 | 107 |
| K163285 | syngo Application Software | LLZ | 2017-02-14 | 84 |
Recalls
openFDA lists no recalls under a recalling firm named Siemens Medical Solution USA, Inc..
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 Medical Solution USA, Inc.'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 Medical Solution USA, Inc. have?
Siemens Medical Solution USA, Inc. has 8 FDA 510(k) clearances (first 2017, latest 2022), across 4 product codes in 1 review panel.
How long does FDA take to clear Siemens Medical Solution USA, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Siemens Medical Solution USA, Inc.'s cleared 510(k)s is 85 days. Since 2017: 85 days, versus 112 days for all cleared 510(k)s in the same product codes.
What devices does Siemens Medical Solution USA, Inc. make?
Its most frequent FDA product codes are LLZ (System, Image Processing, Radiological, 3); OWB (Interventional Fluoroscopic X-Ray System, 3); KPS (System, Tomography, Computed, Emission, 1).
Has Siemens Medical Solution USA, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Siemens Medical Solution USA, Inc. Related entities may recall under other names.
Next steps
- See all 8 Siemens Medical Solution USA, Inc. clearances with predicates and recalls
- Run predicate analysis for product code LLZ, Siemens Medical Solution USA, Inc.'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.