| Primary Device ID | 04260483290312 |
| NIH Device Record Key | 5cf8a5c0-0b3a-4d40-afc8-c0155fbcf63d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | MammoScape |
| Version Model Number | 1.1.4 |
| Company DUNS | 315042296 |
| Company Name | MeVis Medical Solutions AG |
| 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 |
| Phone | 1-866-533-5277 |
| support@mevis.de | |
| Phone | 1-866-533-5277 |
| support@mevis.de | |
| Phone | 1-866-533-5277 |
| support@mevis.de |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04260483290312 [Primary] |
| LMD | System, Digital Image Communications, Radiological |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2026-02-24 |
| Device Publish Date | 2026-02-16 |
| 04260483290312 - MammoScape | 2026-02-24MammoScape 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. |
| 04260483290312 - MammoScape | 2026-02-24 MammoScape is an image viewing software dedicated to breast image display. It is designed to support high performance image read |
| 04260483290282 - MeVis Liver Suite | 2025-05-05 |
| 04260483290244 - Veolity | 2025-01-17 2.2.0, Release date 2024-12-20 |
| 04260483290268 - MeVis Liver Suite | 2024-01-23 |
| 04260483290176 - Veolity | 2021-03-26 |
| 04260483290183 - DynaCAD Lung | 2021-03-26 |
| 04260483290169 - DynaSuite Neuro | 2020-01-16 |
| 04260483290121 - DynaCAD Lung Server | 2020-01-09 2.3.0.224889, Release date: 2017-12-13 2.3.1.239548, Release date: 2019-10-01 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() MAMMOSCAPE 98077468 not registered Live/Pending |
MeVis Medical Solutions AG 2023-07-10 |