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 ID: 04547410327342
• NIH Device Record Key: 8470c9ac-37fa-40f0-93cf-e7b90e695c8f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FDR-2000BPY
• Version Model Number: POSITIONER KIT BPSY HA USA E
• Company DUNS: 713565195
• Company Name: FUJIFILM CORPORATION
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +018002728465
• Email: xxx@xxx.xxx
• Phone: +018002728465
• Email: xxx@xxx.xxx
• Phone: +018002728465
• Email: xxx@xxx.xxx
• Phone: +018002728465
• Email: xxx@xxx.xxx
• Phone: +018002728465
• Email: xxx@xxx.xxx
• Phone: +018002728465
• Email: xxx@xxx.xxx
• Phone: +018002728465
• Email: xxx@xxx.xxx
• Phone: +018002728465
• Email: xxx@xxx.xxx
• Phone: +018002728465
• Email: xxx@xxx.xxx
• Phone: +018002728465
• Email: xxx@xxx.xxx
• Phone: +018002728465
• Email: xxx@xxx.xxx
• Phone: +018002728465
• Email: xxx@xxx.xxx
• Phone: +018002728465
• Email: xxx@xxx.xxx
• Phone: +018002728465
• Email: xxx@xxx.xxx
• Phone: +018002728465
• Email: xxx@xxx.xxx

Operating and Storage Conditions

• Storage Environment Atmospheric Pressure: Between 75 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 75 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 75 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 75 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 75 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 75 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 75 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 75 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 75 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 75 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 75 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 75 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 75 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 75 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 75 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 75 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 75 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 75 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 75 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 75 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 75 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 75 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 75 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 75 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 75 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 75 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 75 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 75 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 75 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 75 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	04547410327342 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133972

FDA Product Code

• IZH: System, X-Ray, Mammographic
• MUE: Full field digital,system,x-ray,mammographic

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-12-14

On-Brand Devices [FDR-2000BPY]

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