510(k) Report

FDA applicant

Dgh Technology, Inc.

Exton, PA7 decisions1987–20170 recalls

FDA records 7 decisions for Dgh Technology, Inc. (Exton, PA) from 1987 to 2017: 7 510(k) clearances. Most are in product codes IYO (System, Imaging, Pulsed Echo, Ultrasonic) and HQC (Unit, Phacofragmentation). Its devices cite 5 predicates, 3 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, radiology panel, where it files most

How often FDA has decided Dgh Technology, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2017

2010: 12017: 1
2007high 1 (2010) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Dgh Technology, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Dgh Technology, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • IYOSystem, Imaging, Pulsed Echo, Ultrasonic6decisions
  • HQCUnit, Phacofragmentation1decision

Whose devices does it build on?

Its devices cite 5 predicates; 3 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 8 times; 3 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K920906DGH-500 PachymeterDgh Technology, Inc. · 19923cite it
  • K872726DGH-3000A a-ScanDgh Technology, Inc. · 19872cite it
  • K913067DGH-4000 a-Scan/PachymeterDgh Technology, Inc. · 19922cite it
  • K093371Model DGH 6000 Scanmate aDgh Technology, Inc. · 20101cites it

What has FDA decided for it lately?

  • K171301Scanmate FlexDgh Technology, Inc. · 2017
  • K093371Model DGH 6000 Scanmate aDgh Technology, Inc. · 2010
  • K033385DGH 55 Handheld Pachymeter (Pachmate)Dgh Technology, Inc. · 2003
  • K965127DGH Model 9000Dgh Technology, Inc. · 1997
  • K920906DGH-500 PachymeterDgh Technology, Inc. · 1992
  • K913067DGH-4000 a-Scan/PachymeterDgh Technology, Inc. · 1992
  • K872726DGH-3000A a-ScanDgh Technology, Inc. · 1987

All 7 as Dgh Technology, Inc. →