Data / Medical devices / South Korea / Neurophet, Inc.
Neurophet, Inc.: FDA-registered device maker in Seoul, South Korea, 6 510(k) clearances
Neurophet, Inc. is registered with the FDA (registration 3025602618) in Seoul, South Korea. It lists 2 device types. The FDA files 6 510(k) clearances under its listings, the newest dated May 15, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3025602618
- Address
- 12F-15F, 314 Gangnam-daero, Gangnam-gu, Republic of Korea, Seoul, South Korea, 06253
- Owner or operator
- NEUROPHET, Inc. (10086951)
- Roles
- Manufacturer
- First device listed
- December 26, 2022
- Registered through
- 2026
- Brand names listed
- Neurophet AQUA, Neurophet AQUA (V3.1), Neurophet AQUA AD Plus, Neurophet SCALE PET
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Automated Radiological Image Processing Software | QIH | 2 | Manufacturer | accessdata.fda.gov |
| System, Image Processing, Radiological | LLZ | 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 |
|---|---|---|---|---|---|---|
| May 15, 2026 | K261273 | Neurophet AQUA | QIH | Substantially Equivalent | Neurophet., Inc. | accessdata.fda.gov |
| May 15, 2026 | K252563 | Neurophet SCALE PET | QIH | Substantially Equivalent | Neurophet., Inc. | accessdata.fda.gov |
| January 29, 2026 | K252496 | Neurophet AQUA AD Plus | QIH | Substantially Equivalent | Neurophet., Inc. | accessdata.fda.gov |
| October 25, 2024 | K242215 | Neurophet AQUA (V3.1) | QIH | Substantially Equivalent | Neurophet., Inc. | accessdata.fda.gov |
| May 10, 2023 | K220437 | Neurophet AQUA | LLZ | Substantially Equivalent | Neurophet., Inc. | accessdata.fda.gov |
| August 5, 2022 | K221405 | Neurophet SCALE PET | LLZ | Substantially Equivalent | Neurophet., Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of System, Image Processing, Radiological
- All makers of Automated Radiological Image Processing Software
Updated May 15, 2026. 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.