The following data is part of a premarket notification filed by Siemens Medical Solutions Usa, Inc. with the FDA for Mammoreport Softcopy Workstation.
| Device ID | K042868 |
| 510k Number | K042868 |
| Device Name: | MAMMOREPORT SOFTCOPY WORKSTATION |
| Classification | System, Image Processing, Radiological |
| Applicant | SIEMENS MEDICAL SOLUTIONS USA, INC. 51 VALLEY STREAM PKWY. Malvern, PA 19355 -1406 |
| Contact | Debra Peacock |
| Correspondent | Debra Peacock SIEMENS MEDICAL SOLUTIONS USA, INC. 51 VALLEY STREAM PKWY. Malvern, PA 19355 -1406 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-10-18 |
| Decision Date | 2005-01-06 |
| Summary: | summary |