PACSgear Enterprise Server

GUDID 00850677007396

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

HYLAND LLC

Radiological PACS software

• Primary Device ID: 00850677007396
• NIH Device Record Key: 1f6e15da-abb8-4cd8-b390-6ebe478b9582
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PACSgear Enterprise Server
• Version Model Number: 5.1.X
• 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	00850677007259 [Previous]
GS1	00850677007396 [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: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2023-10-18
• Device Publish Date: 2020-11-13

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