HealthView CardioPACS 113-00749

GUDID 00857560008003

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.

LUMEDX CORPORATION

Radiology PACS software

• Primary Device ID: 00857560008003
• NIH Device Record Key: a4227dd4-8010-4360-8efe-064d90ebd9df
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HealthView CardioPACS
• Version Model Number: 6.4.0
• Catalog Number: 113-00749
• Company DUNS: 625427471
• Company Name: LUMEDX CORPORATION
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00857560008003 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K120514

FDA Product Code

• LLZ: System, Image Processing, Radiological

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-12-30
• Device Publish Date: 2018-08-13

Devices Manufactured by LUMEDX CORPORATION

• 00857560008003 - HealthView CardioPACS: 2019-12-30CardioPACS 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.
• 00857560008003 - HealthView CardioPACS: 2019-12-30 CardioPACS is a software device intended to be used by medical professionals for storage, review, query/ retrieve, analysis, and
• 00857560008010 - HealthView ECG Manager: 2019-03-11 The HealthView ECG Manager is a computer system, used within a clinical network, which is intended to be used by trained profess