Acuson Corp.: FDA filings under this applicant name
FDA lists 37 510(k) clearances under the applicant name “Acuson Corp.” (first 1988, latest 2002), across 9 product codes in 4 review panels. Median 510(k) review time under this name: 175 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 | 11 | 11 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | 10 | 10 |
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | 7 | 7 |
| MAA | Monitor, Fetal Doppler Ultrasound | 3 | 3 |
| LLZ | System, Image Processing, Radiological | 2 | 2 |
| DQC | Phonocardiograph | 1 | 1 |
| DQO | Catheter, Intravascular, Diagnostic | 1 | 1 |
| FCG | Biopsy Needle | 1 | 1 |
| JTX | Transport Systems, Anaerobic | 1 | 1 |
Review panels
- Radiology (33)
- Cardiovascular (2)
- Gastroenterology and Urology (1)
- Microbiology (1)
Most recent Acuson Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K023772 | KINETDX PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM | LLZ | 2002-11-22 | 10 |
| K022896 | CSV12 SOFTWARE VIEWER | LLZ | 2002-10-03 | 30 |
| K022567 | SEQUOIA SIGNATURE II DIAGNOSTIC ULTRASOUND SYSTEM | IYN | 2002-08-13 | 11 |
| K021497 | CYPRESS ULTRASOUND SYSTEM | IYN | 2002-07-09 | 61 |
| K010950 | CYPRESS SYSTEM | IYO | 2001-06-27 | 90 |
| K002807 | 3D ORGAN ASSESSMENT W/ MAGNETIC POSITION SENSING | IYO | 2000-12-01 | 84 |
| K992631 | ACUNAV DIAGNOSTIC ULTRASOUND CATHETER | DQO | 1999-12-15 | 131 |
| K992580 | FETAL ASSESSMENT CAP | IYO | 1999-10-18 | 77 |
| K991805 | ASPEN ULTRASOUND WITH FREESTYLE IMAGING OPTION | IYN | 1999-08-02 | 68 |
| K973767 | HARMONIC IMAGING WITH CONTRAST | IYO | 1997-12-23 | 82 |
27 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Acuson Corp..
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.
- Acuson Computed Sonography (24 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Acuson Corp.?
FDA lists 37 510(k) clearances under the applicant name “Acuson Corp.” (first 1988, latest 2002), across 9 product codes in 4 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 Acuson Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Acuson Corp. is 175 days.
Which FDA product codes appear under Acuson Corp.?
The most frequent FDA product codes under this applicant name are ITX (Transducer, Ultrasonic, Diagnostic, 11); IYO (System, Imaging, Pulsed Echo, Ultrasonic, 10); IYN (System, Imaging, Pulsed Doppler, Ultrasonic, 7).
Next steps
- See all 37 Acuson Corp. clearances with predicates and recalls
- Run predicate analysis for product code ITX, Acuson Corp.'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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.