LUMEDX CORPORATION

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- Catalog Number : 113-00749

Device Description : CardioPACS is a software device intended to be used by medical professionals for CardioPACS is a software device intended to be used by medical professionals for storage, review, query/ retrieve, analysis, and post processing of DICOM medical images that are generated by echocardiography, radiology, and other modalities. The device can be used as a stand-alone product or in a networked system. CardioPACS is not intended for use with mammograms.

Device Class : 2

Duns Number: 625427471

Premarket Exempt : No

Product Code : LLZ

Prescription Use : No

Device Count : 1

- Catalog Number : 113-01003

Device Description : The HealthView ECG Manager is a computer system, used within a clinical network, The HealthView ECG Manager is a computer system, used within a clinical network, which is intended to be used by trained professionals. It provides the ability to retrieve, store, edit, send, and print ECGs and related digitized clinical documents through the use of on-screen measurement and editing tools. The system receives files (such as ECG, Stress, Holter, or PFT) from any compatible device, displaying such data to the clinician for analysis and review.The product does not modify the original ECG waveform and does not provide an automated ECG analysis.

Device Class : 2

Duns Number: 625427471

Premarket Exempt : No

Product Code : DQK

Prescription Use : No

Device Count : 1