SoftVue 900-00035

GUDID 00860000221306

SoftVue™ Automated Whole Breast Ultrasound System With Sequr™ Breast Interface Assembly

Delphinus Medical Technologies, Inc

Breast ultrasound imaging system Breast ultrasound imaging system Breast ultrasound imaging system Breast ultrasound imaging system

• Primary Device ID: 00860000221306
• NIH Device Record Key: ad796bcb-7265-45c2-a0b0-a72e62706af6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SoftVue
• Version Model Number: Atlantic
• Catalog Number: 900-00035
• Company DUNS: 963425017
• Company Name: Delphinus Medical Technologies, Inc
• 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1 (844) 763-8883
• Email: service@delphinusmt.com
• Phone: 1 (844) 763-8883
• Email: service@delphinusmt.com
• Phone: 1 (844) 763-8883
• Email: service@delphinusmt.com
• Phone: 1 (844) 763-8883
• Email: service@delphinusmt.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 5 Degrees Celsius and 43 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Storage Environment Temperature: Between 5 Degrees Celsius and 43 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Storage Environment Temperature: Between 5 Degrees Celsius and 43 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Storage Environment Temperature: Between 5 Degrees Celsius and 43 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860000221306 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P200040

FDA Product Code

• PAA: Automated Breast Ultrasound

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-12-15
• Device Publish Date: 2022-12-07