Data / Medical devices / South Korea / AIRS Medical Inc.
AIRS Medical Inc.: FDA-registered device maker in Seoul, South Korea, 7 510(k) clearances
AIRS Medical Inc. is registered with the FDA (registration 3024820186) in Seoul, South Korea. It lists 4 device types. The FDA files 7 510(k) clearances under its listings, the newest dated October 1, 2026. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3024820186
- Address
- 13-14F, Keungil Tower 223, Teheran-ro, Gangnam-gu, Seoul, South Korea, 06142
- Owner or operator
- AIRS Medical Inc. (10086333)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- November 2, 2022
- Registered through
- 2027
- Brand names listed
- SwiftMR, SwiftMR (A20-CL and A22-OP), SwiftMR(A20-CL/A22-OP), SwiftSight-BodyComposition, SwiftSight-Brain, SwiftSight-Hub
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Automated Radiological Image Processing Software | QIH | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| System, Digital Image Communications, Radiological | LMD | 1 | Manufacturer | accessdata.fda.gov |
| System, Image Processing, Radiological | LLZ | 2 | Manufacturer | accessdata.fda.gov |
| System, Nuclear Magnetic Resonance Imaging | LNH | 2 | Complaint file establishment, 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 |
|---|---|---|---|---|---|---|
| October 1, 2026 | K261612 | SwiftSight-BodyComposition | LNH | Substantially Equivalent | Airs Medical, Inc. | accessdata.fda.gov |
| July 24, 2026 | K261349 | SwiftMR | QIH | Substantially Equivalent | Airs Medical, Inc. | accessdata.fda.gov |
| March 26, 2026 | K253775 | SwiftMR | QIH | Substantially Equivalent | Airs Medical, Inc. | accessdata.fda.gov |
| September 23, 2025 | K251483 | SwiftSight-Brain | QIH | Substantially Equivalent | Airs Medical, Inc. | accessdata.fda.gov |
| October 27, 2023 | K230854 | SwiftMR | LLZ | Substantially Equivalent | Airs Medical, Inc. | accessdata.fda.gov |
| May 25, 2022 | K220416 | SwiftMR | LLZ | Substantially Equivalent | Airs Medical, Inc. | accessdata.fda.gov |
| October 14, 2021 | K210999 | SwiftMR | LLZ | Substantially Equivalent | Airs Medical, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Automated Radiological Image Processing Software
- All makers of System, Digital Image Communications, Radiological
- All makers of System, Image Processing, Radiological
- All makers of System, Nuclear Magnetic Resonance Imaging
Updated October 1, 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.