510(k) Report

FDA applicant

American Mammographics, Inc.

Chattanooga, TN4 decisions1990–20020 recalls

FDA records 4 decisions for American Mammographics, Inc. (Chattanooga, TN) from 1990 to 2002: 4 510(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 American Mammographics, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for American Mammographics, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — American Mammographics, 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, Mammographic4decisions

Who builds on its devices?

Later devices cite its devices 2 times; 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.

  • K954521Mammospot PaddleAmerican Mammographics, Inc. · 19951cites it
  • K023229S.O.F.T. Paddle (Special Optimized Full Compression Tray), Model SFT-PdleAmerican Mammographics, Inc. · 20021cites it

What has FDA decided for it lately?

  • K023229S.O.F.T. Paddle (Special Optimized Full Compression Tray), Model SFT-PdleAmerican Mammographics, Inc. · 2002
  • K954521Mammospot PaddleAmerican Mammographics, Inc. · 1995
  • K903651Ami MammospotAmerican Mammographics, Inc. · 1990
  • K904517Mammospot 3 and Mammospot 8American Mammographics, Inc. · 1990

All 4 as American Mammographics, Inc. →