PicomEnterprise

GUDID 00861917000305

SCIMAGE, INC

Radiology PACS software

• Primary Device ID: 00861917000305
• NIH Device Record Key: 0ea55c66-7a1a-4d0c-b917-158f106c4470
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PicomEnterprise
• Version Model Number: 3.x
• Company DUNS: 958220790
• Company Name: SCIMAGE, INC
• 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

Customer Support Contacts

• Phone: 866-724-6243
• Email: tech_support@scimage.com
• Phone: 866-724-6243
• Email: tech_support@scimage.com
• Phone: 866-724-6243
• Email: tech_support@scimage.com
• Phone: 866-724-6243
• Email: tech_support@scimage.com
• Phone: 866-724-6243
• Email: tech_support@scimage.com
• Phone: 866-724-6243
• Email: tech_support@scimage.com
• Phone: 866-724-6243
• Email: tech_support@scimage.com
• Phone: 866-724-6243
• Email: tech_support@scimage.com
• Phone: 866-724-6243
• Email: tech_support@scimage.com
• Phone: 866-724-6243
• Email: tech_support@scimage.com
• Phone: 866-724-6243
• Email: tech_support@scimage.com
• Phone: 866-724-6243
• Email: tech_support@scimage.com
• Phone: 866-724-6243
• Email: tech_support@scimage.com
• Phone: 866-724-6243
• Email: tech_support@scimage.com
• Phone: 866-724-6243
• Email: tech_support@scimage.com
• Phone: 866-724-6243
• Email: tech_support@scimage.com
• Phone: 866-724-6243
• Email: tech_support@scimage.com
• Phone: 866-724-6243
• Email: tech_support@scimage.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00861917000305 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K073169

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: 2019-05-23
• Device Publish Date: 2016-09-16