FDA-Device2024-10-30Class II
Trinias unity, Digital Angiography System with Catheterization Table, Model: KS-100 This system consists of the following main components: C arm, catherization table, image processing equipment, x-ray high voltage generator, x-ray tube. There are several types of each component.
SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION
Hazard
If digital angiography system is used with a specific catheterization table and the operator directs simultaneous movement of the table and the C-arm using direct memory, then direct memory button is released, the table may continue to move, which the operator can stop by pressing the stop button.
Sold states
US Nationwide distribution in the states of MA, IL, SC, KY, SC, OH, TN.
Affected count
13
Manufactured in
Nishinokyo Kuwabara -Cho, Nakagyo-Ku; 1, Kyoto, N/A, Japan
Products
Trinias unity, Digital Angiography System with Catheterization Table, Model: KS-100 This system consists of the following main components: C arm, catherization table, image processing equipment, x-ray high voltage generator, x-ray tube. There are several types of each component.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0139-2025Don't want to check this manually?
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