DELTAmanager

GUDID 00861333000309

DELTAmanager is a software package that provides display, review, and communications for Nuclear Medicine, Molecular Imaging, and PET/CT images. DELTAmanager may be used for remote reading on a stand alone workstation or as a plug-in on a PACS workstation.

MEDIMAGE, INC.

Multidisciplinary medical image management software

• Primary Device ID: 00861333000309
• NIH Device Record Key: 825eb7e9-a8bb-42f7-a277-a830902dc838
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DELTAmanager
• Version Model Number: 12
• Company DUNS: 147197602
• Company Name: MEDIMAGE, 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: 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

Customer Support Contacts

• Phone: 734-665-5400
• Email: sales@medimage.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00861333000309 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K933321

FDA Product Code

• KPS: System, Tomography, Computed, Emission

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: 2018-09-24
• Device Publish Date: 2016-09-14