DR-ID 1280MP

GUDID 04547410530636

The DR-ID 1280MP supplies the power to the flat panel sensor connected by a medical professional and establishes intercommunication between the flat panel sensor and the image processing unit connected beforehand. Also, it transfers images acquired by the flat panel sensor to the image processing unit.

FUJIFILM CORPORATION

Diagnostic x-ray digital imaging conversion system
Primary Device ID04547410530636
NIH Device Record Key675dd6c2-6dc6-4653-b79d-b78733d90332
Commercial Distribution StatusIn Commercial Distribution
Brand NameDR-ID 1280MP
Version Model NumberDR-ID 1280 MP 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 Perscriptiontrue
OTC Over-The-Counterfalse

Operating and Storage Conditions

Handling Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -30 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -30 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -30 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -30 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -30 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -30 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -30 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -30 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -30 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -30 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -30 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -30 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -30 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -30 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -30 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -30 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -30 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal

Device Identifiers

Device Issuing AgencyDevice ID
GS104547410530636 [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 Date2024-09-09
Device Publish Date2024-08-30

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