Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

MAC VU360 Resting ECG Analysis System

K-Number: K173830 · 2018-09-18

ApplicantGe Medical Systems Information Technologies, Inc.
Decision Date2018-09-18
Product CodeDPS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MAC VU360 Resting ECG Analysis System is a medical device manufactured by Ge Medical Systems Information Technologies, Inc.. It received FDA 510(k) clearance on 2018-09-18 under approval number K173830. 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 VU360 Resting ECG Analysis System?

MAC VU360 Resting ECG Analysis System is a medical device that received FDA 510(k) clearance on 2018-09-18. It is manufactured by Ge Medical Systems Information Technologies, Inc.. The 510(k) number is K173830.

When was MAC VU360 Resting ECG Analysis System approved by the FDA?

MAC VU360 Resting ECG Analysis System received FDA 510(k) clearance on 2018-09-18, under approval number K173830.

What company makes MAC VU360 Resting ECG Analysis System?

MAC VU360 Resting ECG Analysis System is manufactured by Ge Medical Systems Information Technologies, Inc..

What is the FDA product code for MAC VU360 Resting ECG Analysis System?

The FDA product code for MAC VU360 Resting ECG Analysis System is DPS.

Related Clinical Trials

NCT07475091 Standardizing Swallow Pressure Measurements NOT_YET_RECRUITING NCT02107989 Noninvasive Pre-surgical Evaluation of Patients With Focal Epilepsy and Establishment of a Normative Imaging Database RECRUITING NCT03053791 Deep Brain Stimulation in Patients With Incomplete Spinal Cord Injury for Improvement of Gait RECRUITING NCT03053141 RHythmia mAPping and Signal acquisitiOn for Data analYsis (RHAPSODY) RECRUITING NCT07399574 Diagnostic Accuracy of A Diquat Quantitative Detection Kit and A Portable Mass Spectrometry System for Quantifying Diquat Concentrations in Human Blood Samples NOT_YET_RECRUITING NCT07409545 Autonomic Nervous System Intrapartum Monitoring to Prevent Neonatal Adverse Outcomes NOT_YET_RECRUITING

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 K202189Graffiti K201941Monitor B125, Monitor B105 K203786MAC 7 - Resting ECG Analysis System K222586Mural Clinical Viewer

View all 20 devices →

Related Devices (Code: DPS)

K160746CARDIOLINE touchECGCardioline S.P.A K160840ECG100+, ECG200+Cardioline S.P.A K152135Quantitative Electrocardiographic Detector (QED 2000)Acme Portable Machines, Inc. K161302PC ECGEdan Instruments, Inc. K152863Portable ECG MonitorContec Medical Systems Co.,Ltd K152043Diagnostic Station DS20Schiller AG

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.

↑