Data / Medical devices / United States / DGH Technology, Inc.
DGH Technology, Inc.: FDA-registered device maker in Exton, PA, United States, 7 510(k) clearances
DGH Technology, Inc. is registered with the FDA (registration 2522950) in Exton, PA, United States. It lists 2 device types. The FDA files 7 510(k) clearances under its listings, the newest dated July 31, 2017. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 2522950
- Address
- 110 Summit DR., Suite B, Exton, PA, United States, 19341
- Owner or operator
- DGH TECHNOLOGY, INC. (2522950)
- Roles
- Manufacturer, Repackager or relabeler
- First device listed
- November 14, 2007
- Registered through
- 2026
- Brand names listed
- DGH 3000A, DGH 4000, DGH 5000E, DGH 5100E, DGH 55, DGH 550, DGH 555, DGH 555B and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| System, Imaging, Pulsed Echo, Ultrasonic | IYO | 2 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Transducer, Ultrasonic, Diagnostic | ITX | 2 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| July 31, 2017 | K171301 | Scanmate Flex | IYO | Substantially Equivalent | Dgh Technology, Inc. | accessdata.fda.gov |
| April 5, 2010 | K093371 | MODEL DGH 6000 SCANMATE A | IYO | Substantially Equivalent | Dgh Technology, Inc. | accessdata.fda.gov |
| April 17, 2007 | K070907 | INTERSON USB ULTRASOUND PROBE SYSTEM | IYO | Substantially Equivalent | Regulatory Management Services | accessdata.fda.gov |
| November 7, 2003 | K033385 | DGH 55 HANDHELD PACHYMETER (PACHMATE) | IYO | Substantially Equivalent | Dgh Technology, Inc. | accessdata.fda.gov |
| November 2, 1992 | K920906 | DGH-500 PACHYMETER | IYO | Substantially Equivalent | Dgh Technology, Inc. | accessdata.fda.gov |
| January 31, 1992 | K913067 | DGH-4000 A-SCAN/PACHYMETER | IYO | Substantially Equivalent | Dgh Technology, Inc. | accessdata.fda.gov |
| December 4, 1987 | K872726 | DGH-3000A A-SCAN | IYO | Substantially Equivalent | Dgh Technology, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of System, Imaging, Pulsed Echo, Ultrasonic
- All makers of Transducer, Ultrasonic, Diagnostic
Updated July 31, 2017. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.