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 |