PACSgear Enterprise Server CS.5.2

GUDID 00850677007419

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 folow of data between modalities and destination DICOM systems. PACSgear Enterprise exclusively supports PACSgear client products such as EHR Gateway, Image Link, MDR Video Touch and Web Forms. PACSgear Enterprise Server is not labeled for diagnostic use.

HYLAND LLC

Radiology PACS software

• Primary Device ID: 00850677007419
• NIH Device Record Key: 8946eb97-a8c9-431a-b8e2-23069512f031
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PACSgear Enterprise Server
• Version Model Number: 5.2.X
• Catalog Number: CS.5.2
• Company DUNS: 079941872
• Company Name: HYLAND LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: false
• 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	00850677007419 [Primary]

FDA Product Code

• OUG: Medical Device Data System

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-03-08
• Device Publish Date: 2021-02-26

On-Brand Devices [PACSgear Enterprise Server]

• 00850677007259: Core Server
• 00850677007419: PACSgear Enterprise Server is a program that processes DICOM and non-DICOM medical data includin
• 00850677007396: PACSgear Enterprise Server is a program that processes DICOM and non-DICOM medical data includin