510(k) Report

FDA applicant

Gold Coast Imaging, Inc.

Ft. Lauderdale, FL2 decisions1993–19940 recalls

FDA records 2 decisions for Gold Coast Imaging, Inc. (Ft. Lauderdale, FL) from 1993 to 1994: 2 510(k) clearances. All are in product code IZH (System, X-Ray, Mammographic). 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 Gold Coast Imaging, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Gold Coast Imaging, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Gold Coast Imaging, Inc. 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

Who builds on its devices?

Later devices cite its devices 1 time; 0 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.

  • K933430Cytoguide Stereotatic Biopsy SystemGold Coast Imaging, Inc. · 19941cites it

What has FDA decided for it lately?

  • K933430Cytoguide Stereotatic Biopsy SystemGold Coast Imaging, Inc. · 1994
  • K925212Giotto Patient BedGold Coast Imaging, Inc. · 1993

All 2 as Gold Coast Imaging, Inc. →

Other applicant names beginning “Gold”

FDA records each applicant name separately; these may or may not be the same firm.

Gold Standard Diagnostics 15Gold Standard Orthopaedics, LLC 4Gold Standard Orthopedics, LLC 2Gold, Inc. 1Gold Cadillac Co. 1Gold Link Design, Ltd. 1Gold'N Braces, Inc. 1