GUDID 08806094458213

Digital Flat Panel X-ray Detector used as part of Digital X-ray Imaging System that is intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications.

Samsung Electronics Co., Ltd.

Indirect flat panel x-ray detector Indirect flat panel x-ray detector Indirect flat panel x-ray detector Indirect flat panel x-ray detector Indirect flat panel x-ray detector Indirect flat panel x-ray detector Indirect flat panel x-ray detector Indirect flat panel x-ray detector Indirect flat panel x-ray detector Indirect flat panel x-ray detector Indirect flat panel x-ray detector Indirect flat panel x-ray detector Indirect flat panel x-ray detector
Primary Device ID08806094458213
NIH Device Record Keyc09dc91e-7e15-4b55-ac69-70df3904d6a0
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberS4335-AWM
Company DUNS687967554
Company NameSamsung Electronics 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 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
GS108806094458213 [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 Date2022-05-12
Device Publish Date2022-05-04

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08806094744934 - NA2022-10-28 Digital Flat Panel X-ray Detector used as part of Digital X-ray Imaging System that is intended for use in generating radiograph
08806094458213 - NA2022-05-12Digital Flat Panel X-ray Detector used as part of Digital X-ray Imaging System that is intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications.
08806094458213 - NA2022-05-12 Digital Flat Panel X-ray Detector used as part of Digital X-ray Imaging System that is intended for use in generating radiograph
08806094458220 - NA2022-05-12 Digital Flat Panel X-ray Detector used as part of Digital X-ray Imaging System that is intended for use in generating radiograph
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