The following data is part of a premarket notification filed by Aibolit Technologies, Llc with the FDA for Aibolit 3d+.
| Device ID | K211443 |
| 510k Number | K211443 |
| Device Name: | AIBOLIT 3D+ |
| Classification | System, Image Processing, Radiological |
| Applicant | AIbolit Technologies, LLC 9616 Moritz Way Delray Beach, FL 33446 |
| Contact | Howard Schrayer |
| Correspondent | Howard Schrayer AIbolit Technologies, LLC 9616 Moritz Way Delray Beach, FL 33446 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-05-10 |
| Decision Date | 2022-01-07 |