MammoScape

Basic Information

• Brand Name: MammoScape
• Primary DI: 04260483290312
• Version / Model: 1.1.4
• Company Name: MeVis Medical Solutions AG
• Labeler DUNS: 315042296
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2026-02-16
• Public Version: 1
• Public Version Date: 2026-02-24
• Public Version Status: New
• Public Device Record Key: 5cf8a5c0-0b3a-4d40-afc8-c0155fbcf63d

Device Description

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.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LMD	System, Digital Image Communications, Radiological	Radiology	892.2020	1

GMDN Terms

Code	Name	Definition	Implantable	Status
57812	Radiology DICOM image processing application software	A software application intended to facilitate management, distribution, and/or viewing of radiological digital imaging and communications in medicine (DICOM) image data; it is not intended for pathological image interpretation (i.e., not intended to detect and localize suspected abnormalities). It may be intended to facilitate image management (e.g., viewing, communication, printing, recording/disc burning) and/or image quality manipulation and quantification (e.g., non-interpretive graphical overlays).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04260483290312	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]