Data / Medical devices / South Korea / Purple Ai Inc.
Purple Ai Inc.: FDA-registered device maker in Seocho-gu, Seoul, South Korea, 1 510(k) clearance
Purple Ai Inc. is registered with the FDA (registration 3035495311) in Seocho-gu, Seoul, South Korea. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated July 1, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3035495311
- Address
- Room 107, 111 on the 8th floor of Hongwoo Building, 373, Gangnam-daero, Seocho-gu, Seoul, South Korea, 06621
- Owner or operator
- Purple AI Inc. (10092460)
- Roles
- Manufacturer
- First device listed
- January 16, 2025
- Registered through
- 2026
- Brand names listed
- Hyper Insight
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Radiological Computer-Assisted Triage And Notification Software | QAS | 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 |
|---|---|---|---|---|---|---|
| July 1, 2024 | K240353 | Hyper Insight - ICH | QAS | Substantially Equivalent | Sk, Inc. | accessdata.fda.gov |
Compare with other makers
Updated July 1, 2024. 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.