DRX - Ascend System 1029883

GUDID 60889971029881

LONG LENGTH IMAGING SW FOR DRX-ASCEND

CARESTREAM HEALTH, INC.

Basic diagnostic x-ray system application software
Primary Device ID60889971029881
NIH Device Record Key510289ab-0b7c-45d6-a7bf-2a00802babee
Commercial Distribution Discontinuation2017-11-14
Commercial Distribution StatusNot in Commercial Distribution
Brand NameDRX - Ascend System
Version Model NumberDRX - Ascend System
Catalog Number1029883
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 Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS160889971029881 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MQBSolid state x-ray imager (flat panel/digital imager)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2017-07-24

On-Brand Devices [DRX - Ascend System]

60889978606801KT30-012TRAYINTERFACEKIT KALARE R/FTABLE
60889978604227DRX-ASCEND SYSTEM/QG-50-4-R10-T140
60889978604210DRX-ASCEND SYSTEM/QG-50-3-R10-T140
60889978604203DRX-ASCEND SYSTM/QG-80-3-R10-T920V
60889978604197DRX-ASCEND SYSTM/QG-50-4-R10-T920V
60889978604180DRX-ASCEND SYSTM/QG-50-3-R10-T920V
60889978604173DRX-ASCEND SYSTEM/QG-80-3-R10-T600
60889978604166DRX-ASCEND SYSTEM/QG-50-4-R10-T600
60889978604159DRX-ASCEND SYSTEM/QG-50-3-R10-T600
60889978604111DIG UPGRADE-QRAD LSS FLOOR MOUNT
60889978604050DIG UPGRD-QRAD HSS FLOOR MNT- W/TECHVISN
60889976574638QG-TV10-C TECHVISION RS-590 WITH Q-VISIO
60889976571866TECHVISIN SYSTM,RS-590 WIT
60889974005226TECHVISION FOR CEILING SYSTEM
60889971744852DRX-ASCEND SYSTEM/QGV-80-3-R10-T920V
60889971744845DRX-ASCEND SYSTEM/QGV-40-3-R10-T600
60889971744814DRX-ASCEND SYSTEM/QGV-80-3-R10-T600
60889971744791DRX-ASCEND SYSTEM/QGV-65-3-R10-T920V
60889971744760DRX-ASCEND SYSTEM/QGV-65-3-R10-T600
60889971744753DRX-ASCEND SYSTEM/QGV-65-3-R10-T140
60889971744746DRX-ASCEND SYSTEM/QGV-50-SE-R10-T740
60889971744739DRX-ASCEND SYSTEM/QGV-50-3-R10-T740
60889971744722DRX-ASCEND SYSTEM/QGV-50-2-R10-T740
60889971744715DRX-ASCEND SYSTEM/QGV-50-4-R10-T600
60889971744708DRX-ASCEND SYSTEM/QGV-50-4-R10-T140
60889971744692DRX-ASCEND SYSTEM/QGV-50-2-R10-T600
60889971744685DRX-ASCEND SYSTEM/QGV-50-2-R10-T140
60889971744678DRX-ASCEND SYSTEM/QGV-50-3-R10-T600
60889971744661DRX-ASCEND SYSTEM/QGV-50-3-R10-T140
60889971744647DRX-ASCEND SYSTEM/QGV-40-SE-R10-T600
60889971744616DRX-ASCEND SYSTEM/QGV-40-2-R10-T600
60889971744609DRX-ASCEND SYSTEM/QGV-40-1-R10-T600
60889971744593DRX-ASCEND SYSTEM/QGV-40-SE-R10-T080
60889971744586DRX-ASCEND SYSTEM/QGV-40-3-R10-T080
60889971744579DRX-ASCEND SYSTEM/QGV-40-2-R10-T080
60889971744562DRX-ASCEND SYSTEM/QGV-40-1-R10-T080
60889971744555DRX-ASCEND SYSTEM/QGV-40-SE-R10-T140
60889971744548DRX-ASCEND SYSTEM/QGV-40-SE-R10-T740
60889971744524DRX-ASCEND SYSTEM/QGV-40-3-R10-T140
60889971744517DRX-ASCEND SYSTEM/QGV-40-3-R10-T740
60889971744500DRX-ASCEND SYSTEM/QGV-40-2-R10-T140
60889971744494DRX-ASCEND SYSTEM/QGV-40-2-R10-T740
60889971744487DRX-ASCEND SYSTEM/QGV-40-R10-T140
60889971744470DRX-ASCEND SYSTEM/QGV-40-R10-T740
60889971744456DRX-ASCEND SYSTEM/QGV-32-SE-R10-T140
60889971744449DRX-ASCEND SYSTEM/QGV-32-SE-R10-T740
60889971744432DRX-ASCEND SYSTEM/QGV-32-SE-R10-T080
60889971744425DRX-ASCEND SYSTEM/QGV-32-R10-T140
60889971744418DRX-ASCEND SYSTEM/QGV-32-R10-T740
60889971744401DRX-ASCEND SYSTEM/QGV-32-R10-T080
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