3D Line USA, Inc.
United StatesFDA applicant, unverified
- Devices
- 6
What 3D Line USA, Inc. makes
3D Line USA, Inc. manufactures stereotactic hardware accessories, including the DMLC IV-ERGO, DYNATAC (COD. 50-1A), EVTOOL MODEL # V. 1.0, ERGO SRS, and STEREOTACTIC BODY FRAME (MODEL COD. 70-1A).
The company's devices are Class II and listed in the FDA 510(k) registry. 3D Line USA, Inc. is based in the US.
Catalogue
Dmlc Iv-Ergo Ref K001163
Regimes: 510(k) Registry: 510(k)Dynatrac, Cod. 50-1A Ref K034051
Regimes: 510(k) Registry: 510(k)Evtool Model # V. 1.0 Ref K013535
Regimes: 510(k) Registry: 510(k)Ergo Srs Ref K031281
Regimes: 510(k) Registry: 510(k)3D Line Sterotactic Hardware Accessories Ref K011255
Regimes: 510(k) Registry: 510(k)Stereotactic Body Frame, Model Cod. 70-1A Ref K031631
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does 3D Line USA, Inc. have in the registry?
The registry currently lists 6 devices for 3D Line USA, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list 3D Line USA, Inc.'s devices?
Among its 6 most recently registered devices, 3D Line USA, Inc. has devices listed in FDA 510(k) (6 devices).
What risk classes do 3D Line USA, Inc.'s devices fall under?
Among its 6 most recently registered devices, the classes recorded for 3D Line USA, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from 3D Line USA, Inc. in the registry?
The most recently registered devices listed for 3D Line USA, Inc. include DMLC IV-ERGO, DYNATRAC, COD. 50-1A, EVTOOL MODEL # V. 1.0 and ERGO SRS.