HealthView CardioPACS

Basic Information

• Brand Name: HealthView CardioPACS
• Primary DI: 00857560008003
• Version / Model: 6.4.3
• Catalog Number: 113-00749
• Company Name: LUMEDX CORPORATION
• Labeler DUNS: 625427471
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-08-13
• Public Version: 9
• Public Version Date: 2023-10-18
• Public Version Status: Update
• Public Device Record Key: a4227dd4-8010-4360-8efe-064d90ebd9df

Device Description

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 Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LLZ	System, Image Processing, Radiological	Radiology	892.2050	2

GMDN Terms

Code	Name	Definition	Implantable	Status
41670	Radiological PACS software	An individual software application intended to be installed on a central server as part of a picture archiving and communication system (PACS) to allow storage, retrieval, analysis, and management of radiological images.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00857560008003	GS1

Premarket Submissions

Submission Number	Supplement Number
K120514	000