The following data is part of a premarket notification filed by Adaptiiv with the FDA for 3d Bolus Software Application, 3d Brachy Software Application, Patient-matched 3d Printed Radiation Therapy Accessory.
| Device ID | K213438 |
| 510k Number | K213438 |
| Device Name: | 3D Bolus Software Application, 3D Brachy Software Application, Patient-Matched 3D Printed Radiation Therapy Accessory |
| Classification | System, Planning, Radiation Therapy Treatment |
| Applicant | Adaptiiv 1344 Summer Street Suite 406 Halifax, CA B3h 0a8 |
| Contact | Anastasiia Mereshchuk |
| Correspondent | Anastasiia Mereshchuk Adaptiiv 1344 Summer Street Suite 406 Halifax, CA B3h 0a8 |
| Product Code | MUJ |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-10-22 |
| Decision Date | 2022-01-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10860007402330 | K213438 | 000 |