Max CR System 1056506

GUDID 60889971056504

Max CR system

CARESTREAM HEALTH, INC.

Computed radiography digital imaging scanner
Primary Device ID60889971056504
NIH Device Record Key4e8b1824-0521-4a14-b491-a9d535cbc814
Commercial Distribution StatusIn Commercial Distribution
Brand NameMax CR System
Version Model NumberMax CR System
Catalog Number1056506
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
GS160889971056504 [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 Number9
Public Version Date2020-03-09
Device Publish Date2016-09-16

Devices Manufactured by CARESTREAM HEALTH, INC.

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60889976579367 - Vita Flex CR System2024-07-25 VITA FLEX CR SYSTEM, NB 60PPH WITH PC&MO
60889978625925 - Carestream DRX-1 System2023-07-31 DRX-1 SYSTEM CONSOLE UPGRADE
60889978624768 - DRX-Compass X-ray System2023-07-06 XRAY OTC 80KW 400KHU AUTOTILT CF OSHPD
00889978626487 - D-Speed2023-07-04 100PKT FLASH D-SPEED PERFECT FLM SIZE2
60889978818891 - Ultra-speed2023-07-04 ULTRA-SPEED 150PKT 30.5X40.5 FILM DF58 L
60889976554104 - CARESTREAM DR Long Length Imaging Stand2023-07-04 STEP STOOL FOR LLI

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