Acuson Computed Sonography: FDA filings under this applicant name
FDA lists 24 510(k) clearances under the applicant name “Acuson Computed Sonography” (first 1985, latest 1990), across 7 product codes in 3 review panels. Median 510(k) review time under this name: 94 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 | 10 | 10 |
| JOP | Transducer, Ultrasonic | 6 | 6 |
| HGL | Transducer, Ultrasonic, Obstetric | 3 | 3 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | 2 | 2 |
| DPS | Electrocardiograph | 1 | 1 |
| DPT | Probe, Blood-Flow, Extravascular | 1 | 1 |
Plus 1 more product codes.
Review panels
- Radiology (12)
- Cardiovascular (8)
- Obstetrics and Gynecology (3)
Most recent Acuson Computed Sonography 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K893863 | ACUSON L538 TRANSDUCER | ITX | 1990-05-23 | 364 |
| K874028 | ACUSON S328 TRANSDUCER | IYO | 1988-06-21 | 263 |
| K874861 | ACUSON S328 TRANSDUCER FOR CARDIAC COLOR FLOW APP. | DPT | 1988-05-11 | 166 |
| K874363 | ACUSON S228 AND S328 TRANSDUCERS FOR ABDOM. APPLI. | IYO | 1988-05-02 | 192 |
| K874922 | ACUSON TRANSPERINEAL NEEDLE GUIDE | ITX | 1988-02-19 | 78 |
| K874860 | ACUSON I7505 TRANSDUCER FOR INTRACAVITARY APPLICA. | ITX | 1988-02-17 | 82 |
| K871506 | ACUSON L538 TRANSDUCER | JOP | 1987-09-28 | 164 |
| K871416 | AUXILIARY CONTINUOUS WAVE DOPPLER TRANSDUCER | JOP | 1987-09-28 | 174 |
| K871239 | ACUSON PHYSIOLOGICAL CONTROL MODULE | DPS | 1987-06-05 | 70 |
| K864578 | ACUSON TV519 TRANSDUCER | HGL | 1987-03-27 | 127 |
14 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Acuson Computed Sonography.
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 Corp. (37 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Acuson Computed Sonography?
FDA lists 24 510(k) clearances under the applicant name “Acuson Computed Sonography” (first 1985, latest 1990), across 7 product codes in 3 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 Computed Sonography?
The median time from FDA receipt to decision across 510(k)s cleared under the name Acuson Computed Sonography is 94 days.
Which FDA product codes appear under Acuson Computed Sonography?
The most frequent FDA product codes under this applicant name are ITX (Transducer, Ultrasonic, Diagnostic, 10); JOP (Transducer, Ultrasonic, 6); HGL (Transducer, Ultrasonic, Obstetric, 3).
Next steps
- See all 24 Acuson Computed Sonography clearances with predicates and recalls
- Run predicate analysis for product code ITX, Acuson Computed Sonography'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.