Ge Healthcare (Ge Medical Systems, LLC)

FDA Regulatory Profile

Ge Healthcare (Ge Medical Systems, LLC) has 0 FDA recalls, 0 inspections, 6 510(k) clearances and 0 compliance actions on record.

Latest 510(k)
Jan 20, 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) clearances6Oct 4, 2026Not statedCurrent
Inspections0Oct 25, 2026Not statedCurrent
Compliance actions0Oct 23, 2026Not statedCurrent

Recent 510(k) Clearances

K-NumberDeviceDate
K213668SIGNA HeroJan 20, 2022
K202966SIGNA ArchitectNov 13, 2020
K193282SIGNA PremierApr 10, 2020
K143251SIGNA Creator, SIGNA ExplorerFeb 4, 2015
K132376DISCOVERY MR750 3.0T, DISCOVERY MR450 1.5T, DISCOVERY MR750W 3.0T, OPTIMA MR450W 1.5TNov 15, 2013
K123522OPTIMA MR450WMar 13, 2013