The following data is part of a premarket notification filed by 3d Line Usa, Inc. with the FDA for Evtool Model # V. 1.0.
| Device ID | K013535 |
| 510k Number | K013535 |
| Device Name: | EVTOOL MODEL # V. 1.0 |
| Classification | System, Planning, Radiation Therapy Treatment |
| Applicant | 3D LINE USA, INC. 2807 OLD COURT RD. Baltimore, MD 21208 |
| Contact | Karen Rigamonti |
| Correspondent | Karen Rigamonti 3D LINE USA, INC. 2807 OLD COURT RD. Baltimore, MD 21208 |
| Product Code | MUJ |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-10-23 |
| Decision Date | 2002-01-18 |
| Summary: | summary |