FDR-2000BPY

GUDID 04547410327342

The FDR-2000BPY provides the function that calculates the three-dimensional coordinates of the image obtained from an exposure and supports the positi

FUJIFILM CORPORATION

Stationary mammographic x-ray system, digital
Primary Device ID04547410327342
NIH Device Record Key8470c9ac-37fa-40f0-93cf-e7b90e695c8f
Commercial Distribution StatusIn Commercial Distribution
Brand NameFDR-2000BPY
Version Model NumberPOSITIONER KIT BPSY HA USA 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 Kittrue
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

Operating and Storage Conditions

Storage Environment Atmospheric PressureBetween 75 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius
Handling Environment Atmospheric PressureBetween 75 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 75 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius
Handling Environment Atmospheric PressureBetween 75 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 75 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius
Handling Environment Atmospheric PressureBetween 75 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 75 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius
Handling Environment Atmospheric PressureBetween 75 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 75 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius
Handling Environment Atmospheric PressureBetween 75 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 75 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius
Handling Environment Atmospheric PressureBetween 75 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 75 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius
Handling Environment Atmospheric PressureBetween 75 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 75 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius
Handling Environment Atmospheric PressureBetween 75 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 75 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius
Handling Environment Atmospheric PressureBetween 75 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 75 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius
Handling Environment Atmospheric PressureBetween 75 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 75 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius
Handling Environment Atmospheric PressureBetween 75 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 75 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius
Handling Environment Atmospheric PressureBetween 75 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 75 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius
Handling Environment Atmospheric PressureBetween 75 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 75 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius
Handling Environment Atmospheric PressureBetween 75 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 75 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius
Handling Environment Atmospheric PressureBetween 75 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS104547410327342 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

IZHSystem, X-Ray, Mammographic
MUEFull field digital,system,x-ray,mammographic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-12-14

On-Brand Devices [FDR-2000BPY]

04547410336047The FDR-2000BPY provides the function that calculates the three-dimensional coordinates of the i
04547410327342The FDR-2000BPY provides the function that calculates the three-dimensional coordinates of the i

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