X-ray Flat Panel Detector

GUDID 06970597830479

CareRay Digital Medical Technology Co., Ltd.

Stationary basic diagnostic x-ray system, digital
Primary Device ID06970597830479
NIH Device Record Keye175289a-077c-426d-9b97-454949003ac7
Commercial Distribution StatusIn Commercial Distribution
Brand NameX-ray Flat Panel Detector
Version Model NumberCareView 3600RF
Company DUNS421333508
Company NameCareRay Digital Medical Technology Co., Ltd.
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 Datetrue
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
GS106970597830479 [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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-03-09
Device Publish Date2021-03-01

On-Brand Devices [X-ray Flat Panel Detector]

06970597830363CareView 750Cw
06970597830349CareView 750C
06970597830257CareView 1800Cw
06970597830240CareView 1800L
06970597830219CareView 1800R
06970597830097CareView 1500Cw
06970597830073CareView 1500L
06970597830066CareView 1500C
06970597830035CareView 1500P
06970597830721CareView 1800Le
06970597830745CareView 1800Cwe
06970597830479CareView 3600RF
06970597830271CareView 1800RF
06970597830752EverestView 4343X
06970597832022YosemiteView 4343W
06970597831049YosemiteView 3643W

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