FDA-Device2025-07-30Class II
Portable X-ray system
DIGIMED CO., LTD
Hazard
Some DIOX-602 units currently in use within the United States do not meet the minimum SSD requirement of 18 cm.
Sold states
US
Affected count
530
Manufactured in
401, 402, 406~411-ho, A-dong 101, Gasan digital 2-ro, Geumcheon-Gu, N/A, Seoul, N/A, Korea (the Republic of)
Products
Portable X-ray system
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2117-2025Don't want to check this manually?
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