Gearview QC

GUDID 00850677007051

Gearview QC Software

HYLAND LLC

Radiology PACS software

• Primary Device ID: 00850677007051
• NIH Device Record Key: 655dbaff-a535-47be-a336-68a3180b0c6a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Gearview QC
• Version Model Number: 2
• 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: true
• 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	00850677007051 [Primary]

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: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2019-08-20
• Device Publish Date: 2016-09-16

On-Brand Devices [Gearview QC]

• 00850677007051: Gearview QC Software
• 00850677007334: GearView QC