The following data is part of a premarket notification filed by Claripi Inc. with the FDA for Clarict.ai.
Device ID | K212074 |
510k Number | K212074 |
Device Name: | ClariCT.AI |
Classification | System, Image Processing, Radiological |
Applicant | ClariPi Inc. 3F, 70-15, Ihwajang-gil Seoul, KR 03088 |
Contact | Hyun-sook Park |
Correspondent | Harry Park ClariPi USA Inc. 1645 Park Creek Ct. Rochester Hills, MI 48309 |
Product Code | LLZ |
CFR Regulation Number | 892.2050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2021-07-02 |
Decision Date | 2021-07-27 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
08800046800136 | K212074 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() CLARICT.AI 88550926 not registered Live/Pending |
ClariPI Inc. 2019-07-30 |