Cleared Special

Mac-Lab (AltiX AI.i); CardioLab (AltiX AI.i); ComboLab (AltiX AI.i); MLCL Client Software (AltiX AI.i)

K243540 · Ge Medical Systems Information Technologies, Inc. · Cardiovascular
Dec 2024
Decision
27d
Days
Class 2
Risk

About This 510(k) Submission

K243540 is an FDA 510(k) clearance for the Mac-Lab (AltiX AI.i); CardioLab (AltiX AI.i); ComboLab (AltiX AI.i); MLCL Client Software (AltiX AI.i), a Computer, Diagnostic, Programmable (Class II — Special Controls, product code DQK), submitted by Ge Medical Systems Information Technologies, Inc. (Waukesha, US). The FDA issued a Cleared decision on December 12, 2024, 27 days after receiving the submission on November 15, 2024. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1425.

Submission Details

510(k) Number K243540 FDA.gov
FDA Decision Cleared SESE
Date Received November 15, 2024
Decision Date December 12, 2024
Days to Decision 27 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DQK — Computer, Diagnostic, Programmable
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1425

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