Jumong General— 510(k) K230241

Name: FDA 510(k) clearance K230241
Creator: U.S. Food and Drug Administration
Published: 2023-02-23

Substantially Equivalent

Sg Healthcare Co, Ltd.

FDA 510(k) clearance K230241 for Jumong General, Substantially Equivalent on 2023-02-23. Applicant: Sg Healthcare Co, Ltd.. Device class: 2.

Clearance details

Applicant: Sg Healthcare Co, Ltd.
Product code: Code KPR
Device class: Class 2
Regulation: 21 CFR 892.1680
Advisory panel: Radiology
Date received: 2023-01-30
Decision date: 2023-02-23
Decision: Substantially Equivalent
Clearance type: Special
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 Sg Healthcare Co, Ltd.

view all

K222080 — Garion Image-Intensified Fluoroscopic X-Ray System, Mobile2022-10-06
K150816 — Jumong Series2015-05-08

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.