Siemens Medical Systems, Inc.: FDA filings under this applicant name
FDA lists 25 510(k) clearances under the applicant name “Siemens Medical Systems, Inc.” (first 2001, latest 2014), across 12 product codes in 2 review panels. Median 510(k) review time under this name: 39 days. 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 | 4 | 58 |
| 2013 | 2 | 208 |
| 2014 | 2 | 240 |
| 2015 | 0 | — |
| 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 |
|---|---|---|---|
| JAK | System, X-Ray, Tomography, Computed | 14 | 14 |
| DQK | Computer, Diagnostic, Programmable | 1 | 1 |
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | 1 | 1 |
| IZI | System, X-Ray, Angiographic | 1 | 1 |
| IZL | System, X-Ray, Mobile | 1 | 1 |
| JAA | System, X-Ray, Fluoroscopic, Image-Intensified | 1 | 1 |
| KPR | System, X-Ray, Stationary | 1 | 1 |
| LLZ | System, Image Processing, Radiological | 1 | 1 |
| LNH | System, Nuclear Magnetic Resonance Imaging | 1 | 1 |
| MOS | Coil, Magnetic Resonance, Specialty | 1 | 1 |
Plus 2 more product codes.
Review panels
- Radiology (24)
- Cardiovascular (1)
Most recent Siemens Medical Systems, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K133646 | ADMIRE | JAK | 2014-06-20 | 205 |
| K130901 | SOMATOM DEFINITION AS OPEN | JAK | 2014-01-02 | 276 |
| K123540 | SYNGO CT PULMO 3D | JAK | 2013-08-29 | 283 |
| K123541 | SYNGO.CT NEURO PERFUSION | JAK | 2013-04-02 | 134 |
| K122909 | SYNGO SINGLE SOURCE DUAL ENGERY | JAK | 2012-12-27 | 97 |
| K122471 | SOMATOM DEFINITION | JAK | 2012-09-11 | 28 |
| K120579 | SOMATOM DEFINITION EDGE | JAK | 2012-05-23 | 86 |
| K121072 | SOMATOM DEFINITION FLASH | JAK | 2012-05-08 | 29 |
| K113342 | SOMATOM DEFINITION FLASH | JAK | 2011-12-29 | 45 |
| K052216 | SOMATOM DEFINITION | JAK | 2005-09-08 | 36 |
15 earlier clearances. See the full list in Caduvo.
Recalls
3 product recalls in 3 recall events; 0 initiated in the last five years. Most recent: 2002-11-27.
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 Medical Systems, 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 Medi Cal Solutions, Inc. (32 510(k)s)
- Siemens AG Medical Solutions (31 510(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 Medical Systems, Inc.?
FDA lists 25 510(k) clearances under the applicant name “Siemens Medical Systems, Inc.” (first 2001, latest 2014), 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 Medical Systems, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Siemens Medical Systems, Inc. is 39 days.
Which FDA product codes appear under Siemens Medical Systems, Inc.?
The most frequent FDA product codes under this applicant name are JAK (System, X-Ray, Tomography, Computed, 14); DQK (Computer, Diagnostic, Programmable, 1); IYN (System, Imaging, Pulsed Doppler, Ultrasonic, 1).
Next steps
- See all 25 Siemens Medical Systems, Inc. clearances with predicates and recalls
- Run predicate analysis for product code JAK, Siemens Medical Systems, 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.