PACS Scan CD

GUDID 00850677007112

PACS Scan Software CD

HYLAND LLC

Radiography digital imaging scanner

• Primary Device ID: 00850677007112
• NIH Device Record Key: 99dfe519-6c8e-4ab2-a111-34c52a5828d9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PACS Scan CD
• Version Model Number: 5
• 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	00850677007112 [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: 5
• 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