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FDA 510(k)

MAC 7 Resting ECG Analysis System

K-Number: K251670 · 2026-01-26

ApplicantGe Medical Systems Information Technologies, Inc.
Decision Date2026-01-26
Product CodeDPS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MAC 7 Resting ECG Analysis System is a medical device manufactured by Ge Medical Systems Information Technologies, Inc.. It received FDA 510(k) clearance on 2026-01-26 under approval number K251670. The device is classified under product code DPS. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MAC 7 Resting ECG Analysis System?

MAC 7 Resting ECG Analysis System is a medical device that received FDA 510(k) clearance on 2026-01-26. It is manufactured by Ge Medical Systems Information Technologies, Inc.. The 510(k) number is K251670.

When was MAC 7 Resting ECG Analysis System approved by the FDA?

MAC 7 Resting ECG Analysis System received FDA 510(k) clearance on 2026-01-26, under approval number K251670.

What company makes MAC 7 Resting ECG Analysis System?

MAC 7 Resting ECG Analysis System is manufactured by Ge Medical Systems Information Technologies, Inc..

What is the FDA product code for MAC 7 Resting ECG Analysis System?

The FDA product code for MAC 7 Resting ECG Analysis System is DPS.

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Related PubMed Literature

PMID: 42174947 Aligning AI-Native 6G Healthcare Systems with EU Ethical and Legal Frameworks. Studies in health technology and informatics (2026) PMID: 42056377 Signal detection of adverse events in medical devices using natural language processing: a case study in pelvic mesh. Scientific reports (2026) PMID: 41712188 A Simulation-Based Root Cause Analysis of Pediatric Medication Dosing Errors in Emergency Medical Services. Prehospital emergency care (2026) PMID: 41336744 From laboratory to pre-market prototyping: lessons learned from a noninvasive blood glucose level measurement device. Annual International Conference of the IEEE Engineering in Medicine and Biology Society. IEEE Engineering in Medicine and Biology Society. Annual International Conference (2025)

Other Devices by Ge Medical Systems Information Technologies, Inc.

K152993MUSE Cardiology Information System K170155EK12 Algorithm K173830MAC VU360 Resting ECG Analysis System K202189Graffiti K201941Monitor B125, Monitor B105 K203786MAC 7 - Resting ECG Analysis System

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Related Devices (Code: DPS)

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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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