The following data is part of a premarket notification filed by Ai Medic Inc. with the FDA for Autoseg.
| Device ID | K220039 |
| 510k Number | K220039 |
| Device Name: | AutoSeg |
| Classification | System, Image Processing, Radiological |
| Applicant | AI Medic Inc. 2F, 437, Bongeunsa-ro, Gangnam-gu Seoul, KR KS013/06097 |
| Contact | Jeong Soon Song |
| Correspondent | Jeong Soon Song AI Medic Inc. 2F, 437, Bongeunsa-ro, Gangnam-gu Seoul, KR KS013/06097 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-01-05 |
| Decision Date | 2022-07-20 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() AUTOSEG 97074964 not registered Live/Pending |
AI MEDIC INC. 2021-10-14 |
![]() AUTOSEG 97074947 not registered Live/Pending |
AI MEDIC INC. 2021-10-14 |