Dgh Technology, Inc.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Dgh Technology, Inc.” (first 1987, latest 2017), across 2 product codes in 2 review panels. Median 510(k) review time under this name: 149 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 | 1 | 89 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Dgh Technology, Inc. took a median 89 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 139 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | 6 | 6 |
| HQC | Unit, Phacofragmentation | 1 | 1 |
Review panels
- Radiology (6)
- Ophthalmic (1)
Most recent Dgh Technology, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K171301 | Scanmate Flex | IYO | 2017-07-31 | 89 |
| K093371 | MODEL DGH 6000 SCANMATE A | IYO | 2010-04-05 | 158 |
| K033385 | DGH 55 HANDHELD PACHYMETER (PACHMATE) | IYO | 2003-11-07 | 15 |
| K965127 | DGH MODEL 9000 | HQC | 1997-03-17 | 84 |
| K920906 | DGH-500 PACHYMETER | IYO | 1992-11-02 | 249 |
| K913067 | DGH-4000 A-SCAN/PACHYMETER | IYO | 1992-01-31 | 204 |
| K872726 | DGH-3000A A-SCAN | IYO | 1987-12-04 | 149 |
Recalls
openFDA lists no recalls under a recalling firm named Dgh Technology, 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 Dgh Technology, Inc.?
FDA lists 7 510(k) clearances under the applicant name “Dgh Technology, Inc.” (first 1987, latest 2017), across 2 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 Dgh Technology, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Dgh Technology, Inc. is 149 days.
Which FDA product codes appear under Dgh Technology, Inc.?
The most frequent FDA product codes under this applicant name are IYO (System, Imaging, Pulsed Echo, Ultrasonic, 6); HQC (Unit, Phacofragmentation, 1).
Next steps
- See all 7 Dgh Technology, Inc. clearances with predicates and recalls
- Run predicate analysis for product code IYO, Dgh Technology, 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 (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.