GearView QC GVQC3.0

GUDID 00850677007334

GearView QC

HYLAND LLC

Radiology PACS software

• Primary Device ID: 00850677007334
• NIH Device Record Key: a3b0b1ee-fabc-486f-8a70-203f57f240ea
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GearView QC
• Version Model Number: 3X
• Catalog Number: GVQC3.0
• Company DUNS: 079941872
• Company Name: HYLAND LLC
• 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: false
• Serial Number: true
• Manufacturing Date: true
• 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	00850677007051 [Previous]
GS1	00850677007327 [Primary]
GS1	00850677007334 [Package]; Contains: 00850677007327; Package: [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K083618

FDA Product Code

• LLZ: System, Image Processing, Radiological

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: 2020-10-08
• Device Publish Date: 2020-09-30

On-Brand Devices [GearView QC]

• 00850677007051: Gearview QC Software
• 00850677007334: GearView QC