Data / Medical devices / South Korea / Claripi Inc.
Claripi Inc.: FDA-registered device maker in Seoul, South Korea, 4 510(k) clearances
Claripi Inc. is registered with the FDA (registration 3015537315) in Seoul, South Korea. It lists 4 device types. The FDA files 4 510(k) clearances under its listings, the newest dated April 6, 2022. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3015537315
- Address
- 11 Ihwajang 1-gil, Jongro-gu, Seoul, South Korea, 03100
- Owner or operator
- CLARIPI Inc. (10060777)
- Roles
- Complaint file establishment, Exporter to the US, Manufacturer, Reprocessor, Specification developer
- First device listed
- July 1, 2019
- Registered through
- 2026
- Brand names listed
- ClariCT.AI, ClariPlatform, ClariPulmo, ClariSigmam
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Automated Radiological Image Processing Software | QIH | 2 | Complaint file establishment, Exporter to the US, Manufacturer | accessdata.fda.gov |
| System, Digital Image Communications, Radiological | LMD | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| System, Image Processing, Radiological | LLZ | 2 | Complaint file establishment, Manufacturer, Reprocessor, Specification developer | accessdata.fda.gov |
| System, X-Ray, Tomography, Computed | JAK | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| April 6, 2022 | K203783 | ClariPulmo | LLZ | Substantially Equivalent | Claripi, Inc. | accessdata.fda.gov |
| September 10, 2021 | K203785 | ClariSIGMAM | QIH | Substantially Equivalent | Claripi, Inc. | accessdata.fda.gov |
| July 27, 2021 | K212074 | ClariCT.AI | LLZ | Substantially Equivalent | Claripi, Inc. | accessdata.fda.gov |
| June 13, 2019 | K183460 | ClariCT.AI | LLZ | Substantially Equivalent | Claripi, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of System, Digital Image Communications, Radiological
- All makers of System, Image Processing, Radiological
- All makers of System, X-Ray, Tomography, Computed
- All makers of Automated Radiological Image Processing Software
Updated April 6, 2022. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.