510(k) K243540

Mac-Lab (AltiX AI.i); CardioLab (AltiX AI.i); ComboLab (AltiX AI.i); MLCL Client Software (AltiX AI.i) by Ge Medical Systems Information Technologies, Inc. — Product Code DQK

K243540 is an FDA 510(k) premarket notification submitted by Ge Medical Systems Information Technologies, Inc. for the device "Mac-Lab (AltiX AI.i); CardioLab (AltiX AI.i); ComboLab (AltiX AI.i); MLCL Client Software (AltiX AI.i)". The FDA issued a decision of Substantially Equivalent on December 12, 2024. The device falls under product code DQK (Computer, Diagnostic, Programmable), a Class II device regulated under 21 CFR 870.1425. Ge Medical Systems Information Technologies, Inc. has at least 10 other 510(k) clearances on record.