DRX-Revolution Mobile X-ray System 8612533

GUDID 60889978612499

DRX-REVOLUTION W/TOSHIBA TUBE&CSH GEN

CARESTREAM HEALTH, INC.

Mobile basic diagnostic x-ray system, digital Mobile basic diagnostic x-ray system, digital Mobile basic diagnostic x-ray system, digital Mobile basic diagnostic x-ray system, digital Mobile basic diagnostic x-ray system, digital Mobile basic diagnostic x-ray system, digital Mobile basic diagnostic x-ray system, digital Mobile basic diagnostic x-ray system, digital Mobile basic diagnostic x-ray system, digital Mobile basic diagnostic x-ray system, digital Mobile basic diagnostic x-ray system, digital Mobile basic diagnostic x-ray system, digital Mobile basic diagnostic x-ray system, digital Mobile basic diagnostic x-ray system, digital Mobile basic diagnostic x-ray system, digital Mobile basic diagnostic x-ray system, digital Mobile basic diagnostic x-ray system, digital
Primary Device ID60889978612499
NIH Device Record Keya5bcb4a4-fc7d-4d90-99be-136636a54a26
Commercial Distribution StatusIn Commercial Distribution
Brand NameDRX-Revolution Mobile X-ray System
Version Model NumberDRX-Revolution Mobile X-ray System
Catalog Number8612533
Company DUNS793169512
Company NameCARESTREAM HEALTH, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS160889978612499 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

IZLSystem, x-ray, mobile

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-02-06
Device Publish Date2019-01-06

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

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

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