Siemens Ultrasound, Inc.: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Siemens Ultrasound, Inc.” (first 1989, latest 1991), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 90 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 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 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 |
|---|---|---|---|
| ITX | Transducer, Ultrasonic, Diagnostic | 3 | 3 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | 3 | 3 |
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | 2 | 2 |
Review panels
- Radiology (8)
Most recent Siemens Ultrasound, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K914013 | SIEMENS SI-400 | IYO | 1991-12-02 | 84 |
| K912361 | SI-450/ILUS (INTRALUMINAL ULTRASOUND) | ITX | 1991-12-02 | 187 |
| K911200 | SI-1200 / ILUS | IYO | 1991-06-17 | 90 |
| K904017 | SIEMENS SONOLINE SI-450, OB/GYN,ENT,DENTAL DEVICES | IYN | 1991-03-21 | 203 |
| K910669 | 5 MHZ ADULT/PEDI TRANSESOPHAGEAL ECHO(TEE) TRANSDU | ITX | 1991-03-15 | 28 |
| K910529 | 7.5 MHZ PEDIATRIC TRANSESOPHAGEAL ECHO (TEE) TRANS | ITX | 1991-03-15 | 35 |
| K891449 | SONOLINE CF | IYO | 1989-10-05 | 204 |
| K891238 | SIEMENS TRANSESOPHAGEAL ECHO TEE TRANSDUCER | IYN | 1989-06-05 | 90 |
Recalls
openFDA lists no recalls under a recalling firm named Siemens Ultrasound, 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.
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 Medical Systems, Inc. (25 510(k)s)
- Siemens Healthcare Diagnostics Products GmbH (23 510(k)s)
- Siemens AG (15 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Siemens Ultrasound, Inc.?
FDA lists 8 510(k) clearances under the applicant name “Siemens Ultrasound, Inc.” (first 1989, latest 1991), across 3 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Siemens Ultrasound, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Siemens Ultrasound, Inc. is 90 days.
Which FDA product codes appear under Siemens Ultrasound, Inc.?
The most frequent FDA product codes under this applicant name are ITX (Transducer, Ultrasonic, Diagnostic, 3); IYO (System, Imaging, Pulsed Echo, Ultrasonic, 3); IYN (System, Imaging, Pulsed Doppler, Ultrasonic, 2).
Next steps
- See all 8 Siemens Ultrasound, Inc. clearances with predicates and recalls
- Run predicate analysis for product code ITX, Siemens Ultrasound, 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.