# 3D Line USA, Inc.

- Location (FDA's records): Baltimore, MD
- FDA decisions: 6 (2000–2004): 6 510(k) clearances
- Product codes: IYE (2), MUJ (2), HAW (1), IXI (1)
- Predicates its devices cite: 4 (1 its own); citations of its devices by later devices: 7 (1 its own)
- Recalls linked to its devices: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Elekta Instrument AB: 1 (https://510kreport.com/company/elekta-instrument)
- Nucletron Corp.: 1 (https://510kreport.com/company/nucletron)
- Brainlab AG: 1 (https://510kreport.com/company/brainlab)

## Firms that cite its devices most
- 3D Line Medical Systems S.R.L.: 3 (https://510kreport.com/company/3d-line-medical-systems)
- Direx Systems Corp.: 1 (https://510kreport.com/company/direx-systems)
- Elekta, Ltd.: 1 (https://510kreport.com/company/elekta)
- Computerized Medical Systems, Inc.: 1 (https://510kreport.com/company/computerized-medical-systems)

## Its most-cited devices
- K001163: DMLC IV-Ergo (2000), cited by 5
- K031281: Ergo SRS (2003), cited by 1
- K013535: Evtool Model # V. 1.0 (2002), cited by 1

## Recent decisions
- K034051: Dynatrac, Cod. 50-1A (Apr 5, 2004)
- K031281: Ergo SRS (Dec 23, 2003)
- K031631: Stereotactic Body Frame, Model Cod. 70-1A (Jul 18, 2003)
- K013535: Evtool Model # V. 1.0 (Jan 18, 2002)
- K011255: 3D Line Sterotactic Hardware Accessories (Dec 20, 2001)
- K001163: DMLC IV-Ergo (Oct 23, 2000)

Source page: https://510kreport.com/company/3d-line-usa