The following data is part of a premarket notification filed by Boston Scientific Corporation with the FDA for Lumicoil Platinum Fiducial Marker.
| Device ID | K173251 |
| 510k Number | K173251 |
| Device Name: | LumiCoil Platinum Fiducial Marker |
| Classification | Accelerator, Linear, Medical |
| Applicant | Boston Scientific Corporation 100 Boston Scientific Way Marlborough, MA 01752 |
| Contact | Lindsay Forys |
| Correspondent | Lindsay Forys Boston Scientific Corporation 100 Boston Scientific Way Marlborough, MA 01752 |
| Product Code | IYE |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-10-10 |
| Decision Date | 2017-12-19 |
| Summary: | summary |