EAGLESOFT

GUDID 00350227000063

DICOM NETWORK CD

PATTERSON TECHNOLOGY CENTER

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 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 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 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: 00350227000063
• NIH Device Record Key: bfb12e5a-de6f-4ab9-90ed-7393ef7c1c31
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EAGLESOFT
• Version Model Number: 18.10
• Company DUNS: 062232311
• Company Name: PATTERSON TECHNOLOGY CENTER
• 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: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00350227000063 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K982422

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: 4
• Public Version Date: 2019-05-23
• Device Publish Date: 2016-09-23

On-Brand Devices [EAGLESOFT]

• 00350227000124: EAGLESOFT VERSION 20.00 INSTALL
• 00350227000117: DICOM NETWORK EAGLESOFT VERSION 19.10
• 00350227000100: DICOM MEDIA EAGLESOFT VERSION 19.10
• 00350227000094: EAGLESOFT VERSION 19.10 Install
• 00350227000087: VOICE
• 00350227000070: LORIN LIBRARY
• 00350227000063: DICOM NETWORK CD
• 00350227000056: DICOM MEDIA CD
• 00350227000049: DIGITAL INTEGRATION CD
• 00350227000032: ES DUAL DATABASE (US)
• 00350227000025: EAGLESOFT VERSION 18.10 INSTALL
• 00350227000018: EAGLESOFT VERSION 19.00
• 00350227000209: VOICE EAGLESOFT v21.00
• 00350227000193: LORIN LIBRARY EAGLESOFT v21.00
• 00350227000186: DICOM NETWORK CD EAGLESOFT v21.00
• 00350227000179: DICOM MEDIA EAGLESOFT VERSION 21.00
• 00350227000162: DIGITAL INTEGRATION CD
• 00350227000360: VOICE EAGLESOFT v21.20
• 00350227000353: LORIN LIBRARY EAGLESOFT v21.20
• 00350227000346: DICOM NETWORK CD EAGLESOFT v21.20
• 00350227000339: DICOM MEDIA EAGLESOFT VERSION 21.20
• 00350227000322: DIGITAL INTEGRATION CD VERSION 21.20
• 00350227000315: ES DUAL DATABASE (US) VERSION 21.20
• 00350227000308: EAGLESOFT INSTALL v21.20
• 00350227000292: VOICE EAGLESOFT v21.10
• 00350227000285: LORIN LIBRARY EAGLESOFT v21.10
• 00350227000278: DICOM NETWORK CD EAGLESOFT v21.10
• 00350227000261: DICOM MEDIA EAGLESOFT VERSION 21.10
• 00350227000254: DIGITAL INTEGRATION CD
• 00350227000247: ES DUAL DATABASE (US) VERSION 21.10
• 00350227000230: EAGLESOFT VERSION 21.10 INSTALL
• 00350227000131: EAGLESOFT VERSION 20.10 INSTALL
• 00350227000520: 23