GEAR VIEW QC CD

GUDID 00850677007105

GEAR VIEW QC CD

HYLAND LLC

Radiology PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software

• Primary Device ID: 00850677007105
• NIH Device Record Key: 91f4b9c3-c115-4685-985a-957c435fa06d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GEAR VIEW QC CD
• 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: 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	00850677007105 [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: 2016-09-22

Devices Manufactured by HYLAND LLC

• 00850677007396 - PACSgear Enterprise Server: 2023-10-18 PACSgear Enterprise Server is a program that processes DICOM and non-DICOM medical data including patient demographics, images,
• 00850677007389 - Image Link Plus: 2021-03-08 Image Link Plus supports imaging workflows that do not follow the radiology workflow by providing a pseudo order message to the
• 00850677007419 - PACSgear Enterprise Server: 2021-03-08 PACSgear Enterprise Server is a program that processes DICOM and non-DICOM medical data including patient demographics, images,
• 00850677007334 - GearView QC: 2020-10-08 GearView QC
• 00850677007341 - GearView Basic: 2020-10-08 GearView Basic
• 00850677007259 - PACSgear Enterprise Server: 2020-04-20 Core Server
• 00850677007266 - EHR-Gateway: 2020-04-20
• 00850677007273 - ModLink Web Forms: 2020-04-20 Web Forms