ClariCT.AI
System, Image Processing, Radiological
ClariPi Inc.
The following data is part of a premarket notification filed by Claripi Inc. with the FDA for Clarict.ai.
Pre-market Notification Details
| 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 |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08800046800136 | K212074 | 000 |
| 08800046800211 | K212074 | 000 |
| 08800046800228 | K212074 | 000 |
Trademark Results [ClariCT.AI]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CLARICT.AI 88550926 not registered Live/Pending |
ClariPI Inc. 2019-07-30 |
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