The following data is part of a premarket notification filed by Claripi Inc. with the FDA for Clarisigmam.
| Device ID | K203785 |
| 510k Number | K203785 |
| Device Name: | ClariSIGMAM |
| Classification | Automated Radiological Image Processing Software |
| Applicant | ClariPi Inc. 3F, 70-15, Ihwajang-gil Seoul, KR 03088 |
| Contact | Hyun-sook Park |
| Correspondent | Harry Park ClariPi Detroit Office 1645 Park Creek Ct. Rochester Hills Detroit, MI 48309 |
| Product Code | QIH |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-12-28 |
| Decision Date | 2021-09-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08800046800013 | K203785 | 000 |