510(k) Report

FDA applicant

Giotto USA, LLC

Indianpolis, IN3 decisions2006–20120 recalls

FDA records 3 decisions for Giotto USA, LLC (Indianpolis, IN) from 2006 to 2012: 3 510(k) clearances. Most are in product codes IZH (System, X-Ray, Mammographic) and MUE (Full Field Digital, System, X-Ray, Mammographic). Its devices cite 4 predicates, 1 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 Giotto USA, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2012

2011: 12012: 1
2007high 1 (2011) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Giotto USA, LLC 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
  • MUEFull Field Digital, System, X-Ray, Mammographic1decision

Whose devices does it build on?

Its devices cite 4 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 times; 1 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.

  • K113607Biopsy Digit S Biopsy SLGiotto USA, LLC · 20121cites it
  • K062039Biopsy Digit-AMGiotto USA, LLC · 20061cites it

What has FDA decided for it lately?

  • K113607Biopsy Digit S Biopsy SLGiotto USA, LLC · 2012
  • K111434Giotto Image 3D, Giotto Image 3D-LGiotto USA, LLC · 2011
  • K062039Biopsy Digit-AMGiotto USA, LLC · 2006

All 3 as Giotto USA, LLC →