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DIGIMED CO., LTD

FDA Regulatory Profile

Summary

Total Recalls
1
510(k) Clearances
4
Inspections
1
Compliance Actions
1

Recent Recalls

NumberClassProductDate
Z-2117-2025Class IIPortable X-ray systemJune 19, 2025

Recent 510(k) Clearances

K-NumberDeviceDate
K221587DHX-70H, XTG-70HMarch 3, 2023
K220579Hybrid C70September 1, 2022
K220574HYBRID S70April 22, 2022
K181891Portable X-ray System (Model: MiniX-V, Mini X-S)August 10, 2018