DIGIMED CO., LTD

FDA Regulatory Profile

DIGIMED CO., LTD appears in FDA public data with 1 recall, 4 510(k) clearances, 1 FDA inspection, and 1 compliance action on record. Its most recent recall (Z-2117-2025, Class II) was initiated on Jun 19, 2025. Its most recent 510(k) clearance was granted on Mar 3, 2023.

Summary

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

Known Names

Digimed Co, Digimed

Recent Recalls

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

Recent 510(k) Clearances

K-NumberDeviceDate
K221587DHX-70H, XTG-70HMar 3, 2023
K220579Hybrid C70Sep 1, 2022
K220574HYBRID S70Apr 22, 2022
K181891Portable X-ray System (Model: MiniX-V, Mini X-S)Aug 10, 2018