510(k) Report

FDA applicant

3D Line USA, Inc.

Baltimore, MD6 decisions2000–20045 recalls

FDA records 6 decisions for 3D Line USA, Inc. (Baltimore, MD) from 2000 to 2004: 6 510(k) clearances. Most are in product codes IYE (Accelerator, Linear, Medical) and MUJ (System, Planning, Radiation Therapy Treatment). Its devices cite 4 predicates, 1 of them its own earlier devices. 5 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, radiology panel, where it files most

How often FDA has decided 3D Line USA, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for 3D Line USA, Inc. since 2007.

Recalls per year

3in 2013

2011: 22013: 3
2007high 3 (2013) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — 3D Line USA, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like 3D Line USA, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • IYEAccelerator, Linear, Medical2decisions
  • MUJSystem, Planning, Radiation Therapy Treatment2decisions
  • HAWNeurological Stereotaxic Instrument1decision
  • IXIBlock, Beam-Shaping, Radiation Therapy1decision

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 7 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.

  • K001163DMLC IV-Ergo3D Line USA, Inc. · 20005cite it
  • K031281Ergo SRS3D Line USA, Inc. · 20031cites it
  • K013535Evtool Model # V. 1.03D Line USA, Inc. · 20021cites it

What has FDA decided for it lately?

  • K034051Dynatrac, Cod. 50-1A3D Line USA, Inc. · 2004
  • K031281Ergo SRS3D Line USA, Inc. · 2003
  • K031631Stereotactic Body Frame, Model Cod. 70-1A3D Line USA, Inc. · 2003
  • K013535Evtool Model # V. 1.03D Line USA, Inc. · 2002
  • K0112553D Line Sterotactic Hardware Accessories3D Line USA, Inc. · 20012 recalls
  • K001163DMLC IV-Ergo3D Line USA, Inc. · 20003 recalls

All 6 as 3D Line USA, Inc. →

What has been recalled?

5 recalls linked to its devices; the latest:

  • K001163DMLC IV-ERGO - Beam shaping block for Radiation Therapy.Aug 15, 2013Class II
  • K011255Stereotactic Circular Collimator - 3D Line stereotatic Hardware Accessories The device…Jul 23, 2013Class II
  • K001163DMLC IV-ERGO Product Usage: Intended for use with rotating gantry linear accelerators to…May 1, 2013Class II
  • K001163Dynamic Multileaf Collimator (DMLC) Shapes the radiation beam in treatment therapy.May 25, 2011
  • K011255Stereotactic Circular Collimator Product Usage: This device is intended to hold a…Mar 25, 2011