Data / Medical devices / South Korea / Irm Inc.
Irm Inc.: FDA-registered device maker in Seoul, South Korea, 1 510(k) clearance
Irm Inc. is registered with the FDA (registration 3014055202) in Seoul, South Korea. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated July 9, 2020. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3014055202
- Address
- 8th-2, HongWoo Bldg, 15, Yeoksam-ro 8-gil, Gangnam-gu, Seoul, South Korea, 06250
- Owner or operator
- IRM Inc. (10055970)
- Roles
- Manufacturer
- First device listed
- July 13, 2020
- Registered through
- 2026
- Brand names listed
- I-Rapha View, i-Rapha Solution
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| System, Digital Image Communications, Radiological | LMD | 1 | 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 |
|---|---|---|---|---|---|---|
| July 9, 2020 | K201296 | i-Rapha Solution | LLZ | Substantially Equivalent | Irm, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of System, Digital Image Communications, Radiological
- All makers of System, Image Processing, Radiological
Updated July 9, 2020. 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.