The following data is part of a premarket notification filed by Axial Medical Printing Limited with the FDA for Axial3d Cloud Segmentation Service.
| Device ID | K221511 |
| 510k Number | K221511 |
| Device Name: | Axial3D Cloud Segmentation Service |
| Classification | System, Image Processing, Radiological |
| Applicant | Axial Medical Printing Limited 17A Ormeau Avenue Belfast, GB BT2 8HD |
| Contact | Jenna McGarry |
| Correspondent | Prithul Bom REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2022-05-24 |
| Decision Date | 2022-06-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05065007075005 | K221511 | 000 |