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FDA 510(k)

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

K-Number: K243540 · 2024-12-12

ApplicantGe Medical Systems Information Technologies, Inc.
Decision Date2024-12-12
Product CodeDQK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Mac-Lab (AltiX AI.i); CardioLab (AltiX AI.i); ComboLab (AltiX AI.i); MLCL Client Software (AltiX AI.i) is the device name listed in this FDA 510(k) record. The listed applicant is Ge Medical Systems Information Technologies, Inc.. It received FDA 510(k) clearance on 2024-12-12 under 510(k) number K243540. The device is classified under product code DQK. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Mac-Lab (AltiX AI.i); CardioLab (AltiX AI.i); ComboLab (AltiX AI.i); MLCL Client Software (AltiX AI.i)?

Mac-Lab (AltiX AI.i); CardioLab (AltiX AI.i); ComboLab (AltiX AI.i); MLCL Client Software (AltiX AI.i) is a medical device that received FDA 510(k) clearance on 2024-12-12. The listed applicant is Ge Medical Systems Information Technologies, Inc.. The 510(k) number is K243540.

When did Mac-Lab (AltiX AI.i); CardioLab (AltiX AI.i); ComboLab (AltiX AI.i); MLCL Client Software (AltiX AI.i) receive FDA 510(k) clearance?

Mac-Lab (AltiX AI.i); CardioLab (AltiX AI.i); ComboLab (AltiX AI.i); MLCL Client Software (AltiX AI.i) received FDA 510(k) clearance on 2024-12-12, under 510(k) number K243540.

Who is the listed applicant for Mac-Lab (AltiX AI.i); CardioLab (AltiX AI.i); ComboLab (AltiX AI.i); MLCL Client Software (AltiX AI.i)?

The FDA 510(k) record lists Ge Medical Systems Information Technologies, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Mac-Lab (AltiX AI.i); CardioLab (AltiX AI.i); ComboLab (AltiX AI.i); MLCL Client Software (AltiX AI.i)?

The FDA product code for Mac-Lab (AltiX AI.i); CardioLab (AltiX AI.i); ComboLab (AltiX AI.i); MLCL Client Software (AltiX AI.i) is DQK.

Other records listing Ge Medical Systems Information Technologies, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253277Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125PK251670MAC 7 Resting ECG Analysis SystemK242562Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125PK233810Portrait VSMK234130Portrait™ Mobile Monitoring Solution consists of: • Portrait™ Central Viewer Application (Portrait CVAXB) • Portrait™ Core Services (Portrait CSSXB) • Portrait™ Clinical Alarming Unit (Portrait CAU01) • Portrait™ Mobile Patient Monitor Hardware (Portrait HUBXB) • Portrait™ Mobile Patient Monitor Software (Portrait HSWXB) • Portrait™ Wearable Pulse Oximetry Sensor (Portrait SpO2 P-SA01) • Portrait™ Wearable Pulse Oximetry Sensor (Portrait SpO2 P-SP01) • Portrait™ Wearable Pulse OK231870CASE V7.0 Cardiac Testing System and CardioSoft V7.0 Cardiac Testing System

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Related Devices (Code: DQK)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253576CorVista System® with PCWP Add-OnAnalytics For Life, Inc.K262006EnSite™ X EP SystemAbbott MedicalK252978ScioCardio ECG Analysis PlatformSynergen Technology Labs, LLCK253463ILR ECG Analyzer (IM007)Implicity, Inc.K261119NorthStar Mapping System (MAP01 or MAP01-01)Imricor Medical Systems, Inc.K253088OneStim-DUO Cardiac Stimulator (MP5003-4CO)Micropace Pty, Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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