The following data is part of a premarket notification filed by Medviso Ab with the FDA for Segment 3dprint.
| Device ID | K211966 |
| 510k Number | K211966 |
| Device Name: | Segment 3DPrint |
| Classification | System, Image Processing, Radiological |
| Applicant | Medviso AB Griffelvägen 3 Lund, SE Se-22467 |
| Contact | Einar Heiberg |
| Correspondent | Einar Heiberg Medviso AB Griffelvägen 3 Lund, SE Se-22467 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-06-24 |
| Decision Date | 2022-05-06 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07350010100041 | K211966 | 000 |