DIRECTVIEW CR Long-Length Imaging System 1307123

GUDID 60889971307125

DIRECTVIEW CR LONG-LENGTH IMAGING SYSTEM

CARESTREAM HEALTH, INC.

Computed radiography digital imaging scanner Computed radiography digital imaging scanner

• Primary Device ID: 60889971307125
• NIH Device Record Key: 4e65d33a-ade6-4d19-b8e8-9aa9172f256c
• Commercial Distribution Discontinuation: 2018-04-03
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: DIRECTVIEW CR Long-Length Imaging System
• Version Model Number: DIRECTVIEW CR Long-Length Imaging System
• Catalog Number: 1307123
• 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	60889971307125 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K021829

FDA Product Code

• MQB: Solid state x-ray imager (flat panel/digital imager)

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 8
• Public Version Date: 2019-11-25
• Device Publish Date: 2016-09-16

Devices Manufactured by CARESTREAM HEALTH, INC.

• 60889978625925 - Carestream DRX-1 System: 2023-07-31 DRX-1 SYSTEM CONSOLE UPGRADE
• 60889978624768 - DRX-Compass X-ray System: 2023-07-06 XRAY OTC 80KW 400KHU AUTOTILT CF OSHPD
• 00889978626487 - D-Speed: 2023-07-04 100PKT FLASH D-SPEED PERFECT FLM SIZE2
• 60889978818891 - Ultra-speed: 2023-07-04 ULTRA-SPEED 150PKT 30.5X40.5 FILM DF58 L
• 60889976554104 - CARESTREAM DR Long Length Imaging Stand: 2023-07-04 STEP STOOL FOR LLI
• 60889975950600 - Focus HD 35 Detector: 2023-07-03 FOCUS HD 35 DETECTOR PACK ROK
• 60889975950617 - Focus HD 43 Detector: 2023-07-03 FOCUS HD 43 DETECTOR PACK ROK
• 60889978626007 - DRX-Rise Mobile X-ray System: 2023-06-30 DRX-RISE MOBILE X-RAY SYSTEM