Data / Medical devices / South Korea / JPI Healthcare Co., Ltd
JPI Healthcare Co., Ltd: FDA-registered device maker in Seoul, South Korea, 6 510(k) clearances
JPI Healthcare Co., Ltd is registered with the FDA (registration 3006115340) in Seoul, South Korea. It lists 4 device types. The FDA files 6 510(k) clearances under its listings, the newest dated June 15, 2026. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3006115340
- Address
- 28, Digital-ro 33-gil Woolim e-Biz Center #608, Seoul, South Korea, 08-377
- Owner or operator
- JPI Healthcare Co., Ltd (10023091)
- Roles
- Complaint file establishment, Exporter to the US, Manufacturer
- First device listed
- November 4, 2007
- Registered through
- 2026
- Brand names listed
- EVA 10W, EVA 14W, EVA 17W, ExamVue DR, ExamVue Duo, ExamVue PACS, Grid-1000, Grid-2100 and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Grid, Radiographic | IXJ | 1 | Manufacturer | accessdata.fda.gov |
| Solid State X-Ray Imager (Flat Panel/Digital Imager) | MQB | 2 | Complaint file establishment, Exporter to the US, Manufacturer | accessdata.fda.gov |
| System, Image Processing, Radiological | LLZ | 2 | Manufacturer | accessdata.fda.gov |
| System, X-Ray, Stationary | KPR | 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 |
|---|---|---|---|---|---|---|
| June 15, 2026 | K260482 | DRE Duo | KPR | Substantially Equivalent | Jpi Healthcare Co, Ltd. | accessdata.fda.gov |
| February 24, 2025 | K244010 | ExamVue Apex | MQB | Substantially Equivalent | Jpi Healthcare Co, Ltd. | accessdata.fda.gov |
| February 18, 2022 | K213057 | ExamVue Duo | KPR | Substantially Equivalent | Jpi Healthcare Co, Ltd. | accessdata.fda.gov |
| March 17, 2017 | K162868 | Exam Vue PACS | LLZ | Substantially Equivalent | Jpi Healthcare Solutions, Inc. | accessdata.fda.gov |
| April 17, 2015 | K142930 | Exam Vue DR | KPR | Substantially Equivalent | Jpi Healthcare Co, Ltd. | accessdata.fda.gov |
| January 20, 1995 | K945327 | JPI X-RAY GRID | IXJ | Substantially Equivalent | Jpi America, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of System, X-Ray, Stationary
- All makers of Solid State X-Ray Imager (Flat Panel/Digital Imager)
- All makers of Grid, Radiographic
- All makers of System, Image Processing, Radiological
Updated June 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.