PACSgear Enterprise Server

Basic Information

• Brand Name: PACSgear Enterprise Server
• Primary DI: 00850677007396
• Version / Model: 5.1.X
• Company Name: HYLAND LLC
• Labeler DUNS: 079941872
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-11-13
• Public Version: 2
• Public Version Date: 2023-10-18
• Public Version Status: Update
• Public Device Record Key: 1f6e15da-abb8-4cd8-b390-6ebe478b9582

Device Description

PACSgear Enterprise Server is a program that processes DICOM and non-DICOM medical data including patient demographics, images, videos, and HL7 messages. It also handles user accounts, security, client configuration, and the flow of data between modalities and destination DICOM systems. PACSgear

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: Yes
• Has Serial Number: No
• Has Lot/Batch Number: No
• 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
OUG	Medical Device Data System	General Hospital	880.6310	1

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	00850677007396	GS1
Previous	00850677007259	GS1