CloudDR™

GUDID B269SWR00021MD0

CloudDR™ Medical System Software

Cuattro Medical

Radiology picture archiving and communication system application software

• Primary Device ID: B269SWR00021MD0
• NIH Device Record Key: 482e42bb-99b0-4d36-936c-668d6c18f050
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CloudDR™
• Version Model Number: SWR-00021-MD
• Company DUNS: 014513888
• Company Name: Cuattro Medical
• 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 800-709-4514
• Email: medsupport@cuattro.com
• Phone: 800-709-4514
• Email: medsupport@cuattro.com
• Phone: 800-709-4514
• Email: medsupport@cuattro.com
• Phone: 800-709-4514
• Email: medsupport@cuattro.com
• Phone: 800-709-4514
• Email: medsupport@cuattro.com
• Phone: 800-709-4514
• Email: medsupport@cuattro.com
• Phone: 800-709-4514
• Email: medsupport@cuattro.com
• Phone: 800-709-4514
• Email: medsupport@cuattro.com
• Phone: 800-709-4514
• Email: medsupport@cuattro.com
• Phone: 800-709-4514
• Email: medsupport@cuattro.com
• Phone: 800-709-4514
• Email: medsupport@cuattro.com
• Phone: 800-709-4514
• Email: medsupport@cuattro.com
• Phone: 800-709-4514
• Email: medsupport@cuattro.com
• Phone: 800-709-4514
• Email: medsupport@cuattro.com
• Phone: 800-709-4514
• Email: medsupport@cuattro.com
• Phone: 800-709-4514
• Email: medsupport@cuattro.com
• Phone: 800-709-4514
• Email: medsupport@cuattro.com
• Phone: 800-709-4514
• Email: medsupport@cuattro.com
• Phone: 800-709-4514
• Email: medsupport@cuattro.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B269SWR00021MD0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K093480

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: 2018-09-24
• Device Publish Date: 2016-09-22

Devices Manufactured by Cuattro Medical

• B269SWR00021MD0 - CloudDR™: 2018-09-24CloudDR™ Medical System Software
• B269SWR00021MD0 - CloudDR™: 2018-09-24 CloudDR™ Medical System Software
• B269SWR00069MD0 - CuattroDR: 2018-07-06 CuattroDR System Software