510(k) K230140

TrueView Core 100Pro-US Core Specimen Radiography System (TrueView Core 100Pro-US) by Compai Healthcare (Suzhou) Co.,Ltd — Product Code MWP

K230140 is an FDA 510(k) premarket notification submitted by Compai Healthcare (Suzhou) Co.,Ltd for the device "TrueView Core 100Pro-US Core Specimen Radiography System (TrueView Core 100Pro-US)". The FDA issued a decision of Substantially Equivalent on April 24, 2023. The device falls under product code MWP (Cabinet, X-Ray System), a Class II device regulated under 21 CFR 892.1680. Compai Healthcare (Suzhou) Co.,Ltd has at least 1 other 510(k) clearance on record.