510(k) Report

FDA applicant

3D Line Medical Systems S.R.L.

Milan, IT2 decisions2007–20082 recalls

FDA records 2 decisions for 3D Line Medical Systems S.R.L. (Milan, IT) from 2007 to 2008: 2 510(k) clearances. Most are in product codes HAW (Neurological Stereotaxic Instrument) and MUJ (System, Planning, Radiation Therapy Treatment). Its devices cite 4 predicates, 0 of them its own earlier devices. 2 recalls are linked to its devices.

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

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

How often FDA has decided 3D Line Medical Systems S.R.L.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2008

2007: 12008: 1
2007high 1 (2007) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

1in 2017

2009: 12017: 1
2007high 1 (2009) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — 3D Line Medical Systems S.R.L. 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?

  • HAWNeurological Stereotaxic Instrument1decision
  • MUJSystem, Planning, Radiation Therapy Treatment1decision

Whose devices does it build on?

Its devices cite 4 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 6 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.

  • K080601Ergo++ Version 1.73D Line Medical Systems S.R.L. · 20086cite it

What has FDA decided for it lately?

  • K080601Ergo++ Version 1.73D Line Medical Systems S.R.L. · 20082 recalls
  • K061479ARGOS3D Line Medical Systems S.R.L. · 2007

All 2 as 3D Line Medical Systems S.R.L. →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K080601Elekta ERGO++ Product Usage: ERGO is often used for stereotactic treatments.Sep 1, 2017Class II
  • K080601ERGO++ Stereotactic Radiation Treatment Planning System, ERGO++ Release 1.6.3 and…Dec 11, 2009