The following data is part of a premarket notification filed by Limbus Ai Inc. with the FDA for Limbus Contour.
| Device ID | K201232 |
| 510k Number | K201232 |
| Device Name: | Limbus Contour |
| Classification | System, Image Processing, Radiological |
| Applicant | Limbus AI Inc. 2076 Athol St Regina, CA Sk S4t 3e5 |
| Contact | Jon Giambattista |
| Correspondent | Mary Vater Medical Device Academy 245 Lincoln Hill Rd Shrewsbury, VT 05738 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-05-07 |
| Decision Date | 2020-08-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00628011382146 | K201232 | 000 |
| 00628011382153 | K201232 | 000 |
| 00628011382160 | K201232 | 000 |