QuantumCam 9SYS2070

GUDID 05711665003002

Gamma Camera System

Ddd-Diagnostic A/S

Stationary gamma camera system

• Primary Device ID: 05711665003002
• NIH Device Record Key: 942da5a4-f378-40a1-af25-e8cdf04ddfc3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: QuantumCam
• Version Model Number: QuantumCam Gamma Camera System
• Catalog Number: 9SYS2070
• Company DUNS: 305116642
• Company Name: Ddd-Diagnostic A/S
• 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

Customer Support Contacts

• Phone: 9999999999
• Email: support@ddd-diagnostic.dk

Device Dimensions

• Weight: 2144 Kilogram
• Height: 225 Centimeter
• Depth: 197 Centimeter
• Width: 291 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	05711665003002 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K140206

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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-11-15

On-Brand Devices [QuantumCam]

• 05711665003002: Gamma Camera System
• 05711665003033: Gamma Camera System