Cleared Special

K243540 - Mac-Lab (AltiX AI.i) (FDA 510(k) Clearance)

Also includes:

CardioLab (AltiX AI.i) ComboLab (AltiX AI.i) MLCL Client Software (AltiX AI.i)

Class II Cardiovascular device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K243540 · Ge Medical Systems Information Technologies, Inc. · Cardiovascular device

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Dec 2024

Decision

27d

Days

Class 2

Risk

K243540 is an FDA 510(k) clearance for the Mac-Lab (AltiX AI.i). Classified as Computer, Diagnostic, Programmable (product code DQK), Class II - Special Controls.

Submitted by Ge Medical Systems Information Technologies, Inc. (Waukesha, US). The FDA issued a Cleared decision on December 12, 2024 after a review of 27 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1425 - the FDA cardiovascular device oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Ge Medical Systems Information Technologies, Inc. devices

Submission Details

510(k) Number	K243540 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review	No - reviewed directly by FDA
Combination Product	No
PCCP Authorized	No

Regulatory Context

Review time vs. panel average

98d faster than avg

Panel avg: 125d · This submission: 27d

Pathway characteristics

Modification to existing cleared device.

Device Classification

Product Code	DQK Computer, Diagnostic, Programmable
Device Class	Class 2 - Special Controls
CFR Regulation	21 CFR 870.1425

What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.