MammoScreen

GUDID B885MAML2US0

Radiological computer assisted detection and diagnosis software

THERAPIXEL

X-ray image interpretive software

• Primary Device ID: B885MAML2US0
• NIH Device Record Key: c1a5945a-26a8-483a-9c96-2aa7efc4636d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MammoScreen
• Version Model Number: MAL2US
• Company DUNS: 265235524
• Company Name: THERAPIXEL
• Device Count: 1
• DM Exempt: true
• 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: true
• Serial Number: false
• Manufacturing Date: false
• 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: +33625467635
• Email: support@therapixel.com
• Phone: +33625467635
• Email: support@therapixel.com
• Phone: +33625467635
• Email: support@therapixel.com
• Phone: +33625467635
• Email: support@therapixel.com
• Phone: +33625467635
• Email: support@therapixel.com
• Phone: +33625467635
• Email: support@therapixel.com
• Phone: +33625467635
• Email: support@therapixel.com
• Phone: +33625467635
• Email: support@therapixel.com
• Phone: +33625467635
• Email: support@therapixel.com
• Phone: +33625467635
• Email: support@therapixel.com
• Phone: +33625467635
• Email: support@therapixel.com
• Phone: +33625467635
• Email: support@therapixel.com
• Phone: +33625467635
• Email: support@therapixel.com
• Phone: +33625467635
• Email: support@therapixel.com
• Phone: +33625467635
• Email: support@therapixel.com
• Phone: +33625467635
• Email: support@therapixel.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B885MAML2US0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K211541

FDA Product Code

• QDQ: Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer

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: 2022-01-28
• Device Publish Date: 2022-01-20

On-Brand Devices [MammoScreen]

• B885MAML0: Radiological computer assisted detection and diagnosis software
• B885MAML2US0: Radiological computer assisted detection and diagnosis software