DRX-Revolution Mobile X-ray System 1019405

GUDID 60889971019400

TUBE-GRID ALIGN SYS FOR DRX-REVOLUTION

CARESTREAM HEALTH, INC.

Mobile basic diagnostic x-ray system, digital Mobile basic diagnostic x-ray system, digital

• Primary Device ID: 60889971019400
• NIH Device Record Key: 140fa5ac-96a9-45eb-b8d0-487064bed6d8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DRX-Revolution Mobile X-ray System
• Version Model Number: DRX-Revolution Mobile X-ray System
• Catalog Number: 1019405
• Company DUNS: 793169512
• Company Name: CARESTREAM HEALTH, 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: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	60889971019400 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K120062

FDA Product Code

• IZL: System, x-ray, mobile

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: 2016-09-16

On-Brand Devices [DRX-Revolution Mobile X-ray System]

• 60889978612499: DRX-REVOLUTION W/TOSHIBA TUBE&CSH GEN
• 60889978007257: DRX-MOBILE CONSOLE
• 60889975950013: MOBILE X-RAY GENERATOR
• 60889971060174: DRX-REVOLUTION MOBILE X-RAY SYSTEM
• 60889971019400: TUBE-GRID ALIGN SYS FOR DRX-REVOLUTION
• 60889971019394: DRX-REVOLUTION MOBILE X-RAY SYSTEM
• 60889971002631: DRX-MOBILE CONSOLE
• 60889978618897: DRX REVOLUTION MOBILE X-RAY SYSTEM