DR-ID 1201SE

GUDID 04547410436686

The DR-ID 1201SE and DR-ID 1202SE incorporate a GOS indirect panel. The DR-ID 1211SE, DR-ID 1212SE and DR-ID 1213SE incorporate a CsI indirect panel. The indirect-conversion flat panel sensor is a device which acquires a general radiograph.

FUJIFILM CORPORATION

Diagnostic x-ray digital imaging conversion system Diagnostic x-ray digital imaging conversion system Diagnostic x-ray digital imaging conversion system Diagnostic x-ray digital imaging conversion system Diagnostic x-ray digital imaging conversion system Diagnostic x-ray digital imaging conversion system Diagnostic x-ray digital imaging conversion system Diagnostic x-ray digital imaging conversion system Diagnostic x-ray digital imaging conversion system Diagnostic x-ray digital imaging conversion system Diagnostic x-ray digital imaging conversion system Diagnostic x-ray digital imaging conversion system Diagnostic x-ray digital imaging conversion system Diagnostic x-ray digital imaging conversion system Diagnostic x-ray digital imaging conversion system Diagnostic x-ray digital imaging conversion system Diagnostic x-ray digital imaging conversion system Diagnostic x-ray digital imaging conversion system Diagnostic x-ray digital imaging conversion system Diagnostic x-ray digital imaging conversion system Diagnostic x-ray digital imaging conversion system Diagnostic x-ray digital imaging conversion system Diagnostic x-ray digital imaging conversion system Diagnostic x-ray digital imaging conversion system Diagnostic x-ray digital imaging conversion system Diagnostic x-ray digital imaging conversion system Diagnostic x-ray digital imaging conversion system Diagnostic x-ray digital imaging conversion system
Primary Device ID04547410436686
NIH Device Record Keya1576ec4-9287-435e-9bb3-dfc971a3177f
Commercial Distribution StatusIn Commercial Distribution
Brand NameDR-ID 1201SE
Version Model NumberDR-ID 1201 SE W SDK E
Company DUNS713565195
Company NameFUJIFILM CORPORATION
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 Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+018002728465
Emailxxx@xxx.xxx
Phone+018002728465
Emailxxx@xxx.xxx
Phone+018002728465
Emailxxx@xxx.xxx
Phone+018002728465
Emailxxx@xxx.xxx
Phone+018002728465
Emailxxx@xxx.xxx
Phone+018002728465
Emailxxx@xxx.xxx
Phone+018002728465
Emailxxx@xxx.xxx
Phone+018002728465
Emailxxx@xxx.xxx
Phone+018002728465
Emailxxx@xxx.xxx
Phone+018002728465
Emailxxx@xxx.xxx
Phone+018002728465
Emailxxx@xxx.xxx
Phone+018002728465
Emailxxx@xxx.xxx
Phone+018002728465
Emailxxx@xxx.xxx
Phone+018002728465
Emailxxx@xxx.xxx
Phone+018002728465
Emailxxx@xxx.xxx
Phone+018002728465
Emailxxx@xxx.xxx
Phone+018002728465
Emailxxx@xxx.xxx
Phone+018002728465
Emailxxx@xxx.xxx
Phone+018002728465
Emailxxx@xxx.xxx
Phone+018002728465
Emailxxx@xxx.xxx
Phone+018002728465
Emailxxx@xxx.xxx
Phone+018002728465
Emailxxx@xxx.xxx
Phone+018002728465
Emailxxx@xxx.xxx
Phone+018002728465
Emailxxx@xxx.xxx
Phone+018002728465
Emailxxx@xxx.xxx
Phone+018002728465
Emailxxx@xxx.xxx
Phone+018002728465
Emailxxx@xxx.xxx
Phone+018002728465
Emailxxx@xxx.xxx

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Operating and Storage Conditions

Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween -30 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween -30 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween -30 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween -30 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween -30 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween -30 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween -30 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween -30 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween -30 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween -30 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween -30 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween -30 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween -30 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween -30 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween -30 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween -30 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween -30 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween -30 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween -30 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween -30 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween -30 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween -30 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween -30 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween -30 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween -30 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween -30 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween -30 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween -30 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal

Device Identifiers

Device Issuing AgencyDevice ID
GS104547410436686 [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 Date2020-06-08
Device Publish Date2020-05-31

On-Brand Devices [DR-ID 1201SE]

04547410308501The DR-ID 1201SE and DR-ID 1202SE incorporate a GOS indirect panel. The DR-ID 1211SE, DR-ID 1212
04547410436686The DR-ID 1201SE and DR-ID 1202SE incorporate a GOS indirect panel. The DR-ID 1211SE, DR-ID 1212

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