X-ray Flat Panel Detectors

GUDID 06970597830172

CareRay Digital Medical Technology Co., Ltd.

Portable basic diagnostic x-ray system, digital
Primary Device ID06970597830172
NIH Device Record Key8f6a7485-9aa8-4eaf-a662-c427f6ecee56
Commercial Distribution StatusIn Commercial Distribution
Brand NameX-ray Flat Panel Detectors
Version Model NumberCareView 1500Cwe
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
GS106970597830172 [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 Date2020-08-24
Device Publish Date2020-08-14

Devices Manufactured by CareRay Digital Medical Technology Co., Ltd.

06970597831049 - X-ray Flat Panel Detector2023-09-12
06970597832022 - X-ray Flat Panel Detector2023-09-12
06970597830752 - X-ray Flat Panel Detector2023-02-09
06970597830271 - X-ray Flat Panel Detector2022-09-05
06970597830479 - X-ray Flat Panel Detector2021-03-09
06970597830172 - X-ray Flat Panel Detectors2020-08-24
06970597830172 - X-ray Flat Panel Detectors2020-08-24
06970597830745 - X-ray Flat Panel Detector2020-08-24
06970597830721 - X-ray Flat Panel Detector2019-12-24

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