MammoScape

GUDID 04262459510028

MammoScape is an image viewing software dedicated to breast image display. It is designed to support high performance image reading workflows for the review of high volumes of digital mammography, tomosynthesis, and ultrasound image data (coming from e.g. PACS or scanner) by trained medical professionals. It is intended to be used to display, manipulate, annotate, and export breast images and create reporting information. The software workflow can be individually configured, e.g. to meet the specific requirements of screening or diagnostic purposes.

MeVis BreastCare GmbH & Co. KG

Diagnostic x-ray digital imaging system workstation application software

• Primary Device ID: 04262459510028
• NIH Device Record Key: 25e44186-8638-4ac0-866e-05a54c3b107f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MammoScape
• Version Model Number: 1.1.x
• Company DUNS: 331268636
• Company Name: MeVis BreastCare GmbH & Co. KG
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04262459510028 [Primary]

FDA Product Code

• LMD: System, Digital Image Communications, Radiological

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: 2025-03-12
• Device Publish Date: 2025-03-04

On-Brand Devices [MammoScape]

• 04262459510011: MammoScape is an image viewing software dedicated to breast image display. It is designed to sup
• 04262459510028: MammoScape is an image viewing software dedicated to breast image display. It is designed to sup