JPI Healthcare Co., Ltd
Seoul, KR
JPI Healthcare Co., Ltd appears in FDA device records in Seoul, KR. FDA records list 10 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 10 510(k) clearances for JPI Healthcare Co., Ltd between 1995 and 2026. The busiest year on record is 1996, with 2. The most recent is 2026, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1995 | 1 |
| 1996 | 2 |
| 2011 | 1 |
| 2012 | 1 |
| 2015 | 1 |
| 2016 | 1 |
| 2022 | 1 |
| 2025 | 1 |
| 2026 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K260482 | DRE Duo | KPR | Substantially Equivalent | |
| K244010 | ExamVue Apex | MQB | Substantially Equivalent | |
| K213057 | ExamVue Duo | KPR | Substantially Equivalent | |
| K160143 | ClearVision ExamVue Flat Panel Detector | MQB | Substantially Equivalent | |
| K142930 | Exam Vue DR | KPR | Substantially Equivalent | |
| K102327 | CLEARVISION DR 7000F | MQB | Substantially Equivalent | |
| K101779 | CLEARVISION DR 2000 DIGITAL RADIOGRAPHY X-RAY SYSTEM | KPR | Substantially Equivalent | |
| K955706 | JPI AUTOMATIC X-RAY FILM PROCESSOR | IXW | Substantially Equivalent | |
| K954161 | JPI INTENSIFYING SCREEN | EAM | Substantially Equivalent | |
| K950043 | JPI AUTOMATIC X-RAY FILM PROCESSOR | IXW | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3006115340 | 3006115340 | JPI Healthcare Co., Ltd | 28, Digital-ro 33-gil, Seoul 08-377 KR | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain