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Healcerion Co., Ltd.

FDA Regulatory Profile

Healcerion Co., Ltd. has 0 FDA recalls, 1 inspection, 4 510(k) clearances and 0 compliance actions on record.

Latest inspection
Mar 7, 2025 · VAI
Latest 510(k)
May 16, 2022

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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) clearances4Oct 4, 2026Not statedCurrent
Inspections1Oct 25, 2026Not statedCurrent
Compliance actions0Oct 23, 2026Not statedCurrent

Recent FDA Inspections

DateSiteProductClassificationFEI
Mar 7, 2025Guro District, Korea (The Republic Of)DevicesVoluntary Action Indicated (VAI)3011648943

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
K211665SONON Ultrasound Imaging System, Model: SONON300CMay 16, 2022
K212400SONON Ultrasound Imaging System, Model: SONON 500LApr 22, 2022
K170085SONON Ultrasound Imaging System, Model: 300LOct 12, 2017
K151339SONON Ultrasound Imaging System (Model: SONON 300C)Sep 10, 2015

FDA data resources