Sg Healthcare Co, Ltd.

FDA Regulatory Profile

Sg Healthcare Co, Ltd. has 0 FDA recalls, 1 inspection, 3 510(k) clearances and 0 compliance actions on record.

Latest inspection
Feb 11, 2025 · VAI
Latest 510(k)
Feb 23, 2023

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Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Oct 23, 2026Not statedCurrent
510(k) clearances3Oct 4, 2026Not statedCurrent
Inspections1Oct 25, 2026Not statedCurrent
Compliance actions0Oct 23, 2026Not statedCurrent

Recent FDA Inspections

DateSiteProductClassificationFEI
Feb 11, 2025Icheon, Korea (The Republic Of)DevicesVoluntary Action Indicated (VAI)3009715136

NAI means no objectionable conditions or practices were found during the inspection. VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action. OAI means regulatory and/or administrative actions are recommended.

Recent 510(k) Clearances

K-NumberDeviceDate
K230241Jumong GeneralFeb 23, 2023
K222080Garion Image-Intensified Fluoroscopic X-Ray System, MobileOct 6, 2022
K150816Jumong SeriesMay 8, 2015