The following data is part of a premarket notification filed by Radiation Products Llc with the FDA for Accusyte 3d Fiducial Marker.
| Device ID | K180027 |
| 510k Number | K180027 |
| Device Name: | ACCUSYTE 3D Fiducial Marker |
| Classification | Accelerator, Linear, Medical |
| Applicant | Radiation Products LLC 142 JFK Drive Atlantis, FL 33462 |
| Contact | John D Corbitt |
| Correspondent | Victor Pereira VHP Consulting 7240 NW 63 Terrace Parkland, FL 33067 |
| Product Code | IYE |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-01-03 |
| Decision Date | 2018-07-18 |
| Summary: | summary |