The following data is part of a premarket notification filed by Image Diagnost International Gmbh with the FDA for Mammoworkstation.
| Device ID | K123575 |
| 510k Number | K123575 |
| Device Name: | MAMMOWORKSTATION |
| Classification | System, Image Processing, Radiological |
| Applicant | IMAGE DIAGNOST INTERNATIONAL GMBH 283 RUE DE LA MINIERE Buc, FR 78530 |
| Contact | Mounir Zaouali |
| Correspondent | Mounir Zaouali IMAGE DIAGNOST INTERNATIONAL GMBH 283 RUE DE LA MINIERE Buc, FR 78530 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-11-20 |
| Decision Date | 2013-02-19 |
| Summary: | summary |