The following data is part of a premarket notification filed by Ge Healthcare with the FDA for Mammo Workstation.
| Device ID | K143361 |
| 510k Number | K143361 |
| Device Name: | Mammo Workstation |
| Classification | System, Image Processing, Radiological |
| Applicant | GE HEALTHCARE Oskar-Schlemmer-Str. 11 Munich, DE D-80807 |
| Contact | Mounir Zaouali |
| Correspondent | Mounir Zaouali GE HEALTHCARE Oskar-Schlemmer-Str. 11 Munich, DE D-80807 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-11-24 |
| Decision Date | 2015-03-26 |
| Summary: | summary |