XDR XDRSW

GUDID D787XDRSW1

Dental imaging software

CYBER MEDICAL IMAGING, INC.

General-purpose dental x-ray system application software General-purpose dental x-ray system application software

• Primary Device ID: D787XDRSW1
• NIH Device Record Key: df5a2264-a4d5-4301-af20-23d23c99355b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: XDR
• Version Model Number: Imaging Software
• Catalog Number: XDRSW
• Company DUNS: 112029934
• Company Name: CYBER MEDICAL IMAGING, 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: true
• 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: 8889379729
• Email: service@xdrRadiology.com
• Phone: 8889379729
• Email: service@xdrRadiology.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D787XDRSW1 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K013271

FDA Product Code

• MUH: System,X-Ray,Extraoral Source,Digital

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: 2016-12-31

On-Brand Devices [XDR]

• D787XDRSW300: Dental imaging software
• D787XDRSW1: Dental imaging software
• D787215AC25B130A0: Dental digital intraoral sensor, size 1
• D787215AC25B11: Dental digital intraoral sensor, size 1
• D787213AC25B130A0: Dental digital intraoral sensor, size 2
• D787213AC25B11: Dental digital intraoral sensor, size 2