Oec-Diasonics, Inc.: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Oec-Diasonics, Inc.” (first 1985, latest 1993), across 4 product codes in 2 review panels. Median 510(k) review time under this name: 91 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 GE HealthCare, 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 |
|---|---|---|---|
| JAA | System, X-Ray, Fluoroscopic, Image-Intensified | 5 | 5 |
| IXR | Table, Radiographic, Tilting | 1 | 1 |
| KQS | Table, Cystometric, Non-Electric And Accessories | 1 | 1 |
| OXO | Image-Intensified Fluoroscopic X-Ray System, Mobile | 1 | 1 |
Review panels
Most recent Oec-Diasonics, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K926056 | 9600 FLUOROSCOPIC IMAGING SYSTEM | OXO | 1993-01-21 | 51 |
| K924879 | EP 3000 | JAA | 1993-01-04 | 98 |
| K914446 | UROVIEW 2000, MODIFICATION | JAA | 1992-01-10 | 98 |
| K896583 | F.A.S.T. TABLE | IXR | 1990-03-01 | 100 |
| K893475 | UROVIEW II | JAA | 1989-08-10 | 98 |
| K872022 | UROVIEW | KQS | 1987-07-16 | 51 |
| K864837 | MODIFIED MAINFRAME OF MODEL 902 MOBILE C-ARM | JAA | 1987-01-30 | 52 |
| K843972 | ANGIOPLUS-S | JAA | 1985-01-03 | 84 |
Recalls
openFDA lists no recalls under a recalling firm named Oec-Diasonics, 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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Oec-Diasonics, Inc.?
FDA lists 8 510(k) clearances under the applicant name “Oec-Diasonics, Inc.” (first 1985, latest 1993), across 4 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 Oec-Diasonics, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Oec-Diasonics, Inc. is 91 days.
Which FDA product codes appear under Oec-Diasonics, Inc.?
The most frequent FDA product codes under this applicant name are JAA (System, X-Ray, Fluoroscopic, Image-Intensified, 5); IXR (Table, Radiographic, Tilting, 1); KQS (Table, Cystometric, Non-Electric And Accessories, 1).
Next steps
- See all 8 Oec-Diasonics, Inc. clearances with predicates and recalls
- Run predicate analysis for product code JAA, Oec-Diasonics, 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.