The following data is part of a premarket notification filed by 3d Systems with the FDA for Vsp Bolus.
| Device ID | K214093 |
| 510k Number | K214093 |
| Device Name: | VSP Bolus |
| Classification | Block, Beam-shaping, Radiation Therapy |
| Applicant | 3D Systems 5381 S Alkire Circle Littleton, CO 80127 |
| Contact | Benjamin Johnson |
| Correspondent | Benjamin Johnson 3D Systems 5381 S Alkire Circle Littleton, CO 80127 |
| Product Code | IXI |
| CFR Regulation Number | 892.5710 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-12-28 |
| Decision Date | 2022-03-30 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816847022613 | K214093 | 000 |