510(k) Report

FDA applicant

Digitec Medical Service Corp.

Lawrenceville, GA2 decisions1999–20010 recalls

FDA records 2 decisions for Digitec Medical Service Corp. (Lawrenceville, GA) from 1999 to 2001: 2 510(k) clearances. All are in product code IZH (System, X-Ray, Mammographic). Its devices cite 1 predicate, 0 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 Digitec Medical Service Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Digitec Medical Service Corp. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Digitec Medical Service Corp. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • IZHSystem, X-Ray, Mammographic2decisions

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K010792MammographDigitec Medical Service Corp. · 2001
  • K993681Digitec Two Stage Compression KitDigitec Medical Service Corp. · 1999

All 2 as Digitec Medical Service Corp. →