ASPIRE Cristalle

GUDID 04547410297546

The Fujifilm Digital Mammography Systems, ASPIRE Cristalle (FDR MS-3500) generates full-field digital mammography images that can, as other full-field

FUJIFILM CORPORATION

Stationary mammographic x-ray system, digital

• Primary Device ID: 04547410297546
• NIH Device Record Key: e79e11bc-089e-45c5-b602-ffb2066ed312
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ASPIRE Cristalle
• Version Model Number: DR 3500 W 24X30 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: false
• 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
• 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 Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 75 KiloPascal and 106 KiloPascal
• Storage Environment Atmospheric Pressure: Between 75 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 75 KiloPascal and 106 KiloPascal
• Storage Environment Atmospheric Pressure: Between 75 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 75 KiloPascal and 106 KiloPascal
• Storage Environment Atmospheric Pressure: Between 75 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 75 KiloPascal and 106 KiloPascal
• Storage Environment Atmospheric Pressure: Between 75 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 75 KiloPascal and 106 KiloPascal
• Storage Environment Atmospheric Pressure: Between 75 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 75 KiloPascal and 106 KiloPascal
• Storage Environment Atmospheric Pressure: Between 75 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 75 KiloPascal and 106 KiloPascal
• Storage Environment Atmospheric Pressure: Between 75 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 75 KiloPascal and 106 KiloPascal
• Storage Environment Atmospheric Pressure: Between 75 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 75 KiloPascal and 106 KiloPascal
• Storage Environment Atmospheric Pressure: Between 75 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 75 KiloPascal and 106 KiloPascal
• Storage Environment Atmospheric Pressure: Between 75 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 75 KiloPascal and 106 KiloPascal
• Storage Environment Atmospheric Pressure: Between 75 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 75 KiloPascal and 106 KiloPascal
• Storage Environment Atmospheric Pressure: Between 75 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 75 KiloPascal and 106 KiloPascal
• Storage Environment Atmospheric Pressure: Between 75 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 75 KiloPascal and 106 KiloPascal
• Storage Environment Atmospheric Pressure: Between 75 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 75 KiloPascal and 106 KiloPascal
• Storage Environment Atmospheric Pressure: Between 75 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 75 KiloPascal and 106 KiloPascal
• Storage Environment Atmospheric Pressure: Between 75 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 75 KiloPascal and 106 KiloPascal
• Storage Environment Atmospheric Pressure: Between 75 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 75 KiloPascal and 106 KiloPascal
• Storage Environment Atmospheric Pressure: Between 75 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 75 KiloPascal and 106 KiloPascal
• Storage Environment Atmospheric Pressure: Between 75 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 75 KiloPascal and 106 KiloPascal
• Storage Environment Atmospheric Pressure: Between 75 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 75 KiloPascal and 106 KiloPascal
• Storage Environment Atmospheric Pressure: Between 75 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 75 KiloPascal and 106 KiloPascal
• Storage Environment Atmospheric Pressure: Between 75 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 75 KiloPascal and 106 KiloPascal
• Storage Environment Atmospheric Pressure: Between 75 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 75 KiloPascal and 106 KiloPascal
• Storage Environment Atmospheric Pressure: Between 75 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 75 KiloPascal and 106 KiloPascal
• Storage Environment Atmospheric Pressure: Between 75 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 75 KiloPascal and 106 KiloPascal
• Storage Environment Atmospheric Pressure: Between 75 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 75 KiloPascal and 106 KiloPascal
• Storage Environment Atmospheric Pressure: Between 75 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 75 KiloPascal and 106 KiloPascal
• Storage Environment Atmospheric Pressure: Between 75 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	04547410297546 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133972

FDA Product Code

• 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: 2016-09-16

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