Diagnostic Ultrasound Corp.: FDA filings under this applicant name
FDA lists 16 510(k) clearances under the applicant name “Diagnostic Ultrasound Corp.” (first 1985, latest 2003), across 9 product codes in 4 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.
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 |
|---|---|---|---|
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | 6 | 6 |
| FAP | Cystometric Gas (Carbon-Dioxide) On Hydraulic Device | 3 | 3 |
| DPW | Flowmeter, Blood, Cardiovascular | 1 | 1 |
| DXT | Injector And Syringe, Angiographic | 1 | 1 |
| EXY | Uroflowmeter | 1 | 1 |
| FFX | System, Gastrointestinal Motility (Electrical) | 1 | 1 |
| ITX | Transducer, Ultrasonic, Diagnostic | 1 | 1 |
| JOP | Transducer, Ultrasonic | 1 | 1 |
| LLZ | System, Image Processing, Radiological | 1 | 1 |
Review panels
Most recent Diagnostic Ultrasound Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K030763 | DIAGNOSTIC ULTRASOUND BLADDERMASS BVM 6500 ULTRASOUND SYSTEM | IYO | 2003-03-26 | 15 |
| K022153 | BLADDERSCAN BVI 6100 | IYO | 2002-08-15 | 44 |
| K982568 | BLADDERMANAGER PCI 5000 MODEL 1002 | ITX | 1999-01-25 | 186 |
| K963585 | BLADDER MANAGER PCI 5000, BLADDERSCAN BVI 5000 | IYO | 1996-10-01 | 22 |
| K955840 | BLADDERMANAGER PCI 5000 / BLADDERSCAN BVI 5000 | IYO | 1996-05-24 | 150 |
| K955942 | BLADDERSCAN BVI 5000 | IYO | 1996-03-15 | 80 |
| K920664 | DIAGNOSTIC ULTRASOUND/URO-GYN UPS 2020, GI VERSION | FFX | 1993-12-23 | 679 |
| K915342 | UD 2000 VIDEO OPTION | LLZ | 1992-06-10 | 197 |
| K915436 | BLADDERSCAN BVI 2500 | IYO | 1992-03-03 | 90 |
| K911166 | DIAGNOSTIC ULTRASOUND/URO-GYN UD 511 | DXT | 1991-08-15 | 153 |
6 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Diagnostic Ultrasound 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.
- Diagnostic Products Corp. (324 510(k)s)
- Diagnostic Systems Laboratories, Inc. (94 510(k)s)
- Diagnostic Chemicals, Ltd. (Usa) (77 510(k)s)
- Diagnostic Chemicals , Ltd. (66 510(k)s)
- Diagnostic Reagents, Inc. (66 510(k)s)
- Diagnostic Hybrids, Inc. (36 510(k)s)
- Diagnostic Technology, Inc. (28 510(k)s)
- Diagnostic Solutions, Inc. (26 510(k)s)
- Diagnostic Systems (14 510(k)s)
- Diagnostic Reagent Tech. (10 510(k)s)
- Diagnostic Specialties (8 510(k)s)
- Diagnostic Medical Instruments (5 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Diagnostic Ultrasound Corp.?
FDA lists 16 510(k) clearances under the applicant name “Diagnostic Ultrasound Corp.” (first 1985, latest 2003), 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 Diagnostic Ultrasound Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Diagnostic Ultrasound Corp. is 94 days.
Which FDA product codes appear under Diagnostic Ultrasound Corp.?
The most frequent FDA product codes under this applicant name are IYO (System, Imaging, Pulsed Echo, Ultrasonic, 6); FAP (Cystometric Gas (Carbon-Dioxide) On Hydraulic Device, 3); DPW (Flowmeter, Blood, Cardiovascular, 1).
Next steps
- See all 16 Diagnostic Ultrasound Corp. clearances with predicates and recalls
- Run predicate analysis for product code IYO, Diagnostic Ultrasound 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, 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.