Siemens Medi Cal Solutions, Inc.: FDA filings under this applicant name
FDA lists 32 510(k) clearances under the applicant name “Siemens Medi Cal Solutions, Inc.” (first 2004, latest 2020), across 12 product codes in 2 review panels. Median 510(k) review time under this name: 102 days. Since 2017 the median was 120 days, against 111 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 | 1 | 175 |
| 2013 | 2 | 21 |
| 2014 | 4 | 225 |
| 2015 | 2 | 111 |
| 2016 | 5 | 116 |
| 2017 | 2 | 45 |
| 2018 | 4 | 134 |
| 2019 | 2 | 146 |
| 2020 | 1 | 109 |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Siemens Medi Cal Solutions, Inc. took a median 120 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 111 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | 7 | 7 |
| LNH | System, Nuclear Magnetic Resonance Imaging | 5 | 5 |
| JAK | System, X-Ray, Tomography, Computed | 4 | 4 |
| KPR | System, X-Ray, Stationary | 3 | 3 |
| LLZ | System, Image Processing, Radiological | 3 | 3 |
| OWB | Interventional Fluoroscopic X-Ray System | 3 | 3 |
| DQK | Computer, Diagnostic, Programmable | 2 | 2 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | 1 | 1 |
| IZL | System, X-Ray, Mobile | 1 | 1 |
| MOS | Coil, Magnetic Resonance, Specialty | 1 | 1 |
Plus 2 more product codes.
Review panels
- Radiology (30)
- Cardiovascular (2)
Most recent Siemens Medi Cal Solutions, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K193216 | syngo.CT Lung CAD | OEB | 2020-03-09 | 109 |
| K182639 | MOBILETT Elara Max | IZL | 2019-03-15 | 172 |
| K182517 | MULTIX Impact | KPR | 2019-01-11 | 120 |
| K181279 | Ysio Max | KPR | 2018-06-13 | 29 |
| K173639 | Luminos dRF Max, Luminos Agile Max, Uroskop Omnia Max, Multitom Rax | OWB | 2018-04-02 | 129 |
| K173408 | Mammomat Revelation | MUE | 2018-03-21 | 140 |
| K172832 | Insight BD | LLZ | 2018-02-06 | 140 |
| K171766 | Acuson SC2000 Diagnostic Ultrasound System | IYO | 2017-07-12 | 28 |
| K170315 | Acuson SC2000 Diagnostic Ultrasound System | IYN | 2017-04-04 | 62 |
| K162102 | MAGNETOM Avantofit, MAGNETOM Skyrafit | LNH | 2016-11-22 | 116 |
22 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Siemens Medi Cal Solutions, Inc..
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 Medi Cal Solutions, Inc. (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 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)
- Siemens Medical Electronics (15 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Siemens Medi Cal Solutions, Inc.?
FDA lists 32 510(k) clearances under the applicant name “Siemens Medi Cal Solutions, Inc.” (first 2004, latest 2020), across 12 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 Medi Cal Solutions, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Siemens Medi Cal Solutions, Inc. is 102 days. Since 2017: 120 days, versus 111 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Siemens Medi Cal Solutions, Inc.?
The most frequent FDA product codes under this applicant name are IYN (System, Imaging, Pulsed Doppler, Ultrasonic, 7); LNH (System, Nuclear Magnetic Resonance Imaging, 5); JAK (System, X-Ray, Tomography, Computed, 4).
Next steps
- See all 32 Siemens Medi Cal Solutions, Inc. clearances with predicates and recalls
- Run predicate analysis for product code IYN, Siemens Medi Cal Solutions, Inc.'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.