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 |