ExamVue Duo— 510(k) K213057

Name: FDA 510(k) clearance K213057
Creator: U.S. Food and Drug Administration
Published: 2022-02-18

Substantially Equivalent

Jpi Healthcare Co, Ltd.

FDA 510(k) clearance K213057 for ExamVue Duo, Substantially Equivalent on 2022-02-18. Applicant: Jpi Healthcare Co, Ltd.. Device class: 2.

Clearance details

Applicant: Jpi Healthcare Co, Ltd.
Product code: Code KPR
Device class: Class 2
Regulation: 21 CFR 892.1680
Advisory panel: Radiology
Date received: 2021-09-22
Decision date: 2022-02-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Seoul, KR

Download summary PDF View on FDA.gov ↗

Recent devices under product code KPR

view all

K260227 — EXSYS DEXi (EXSYS DEXi-S40S); EXSYS DEXi (EXSYS DEXi-S40P); EXSYS DEXi (EXSYS DEXi-S40T); EXSYS DEXi (EXSYS DEXi-S50H2026-09-08
K260488 — MULTIX Impact; MULTIX Impact C2026-08-31
K260481 — GC85A2026-08-27
K260482 — DRE Duo2026-06-15
K253446 — AeroDR TX c022026-04-10

More clearances from Jpi Healthcare Co, Ltd.

view all

K244010 — ExamVue Apex2025-02-24
K142930 — Exam Vue DR2015-04-17
K102327 — CLEARVISION DR 7000F2012-04-13
K101779 — CLEARVISION DR 2000 DIGITAL RADIOGRAPHY X-RAY SYSTEM2011-05-16
K955706 — JPI AUTOMATIC X-RAY FILM PROCESSOR1996-02-12

Adverse events under product code KPR

product code KPR

Other: 6
Total: 6

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.