The following data is part of a premarket notification filed by Image Diagnost International Gmbh with the FDA for Mammo Workstation.
| Device ID | K081630 |
| 510k Number | K081630 |
| Device Name: | MAMMO WORKSTATION |
| Classification | System, Image Processing, Radiological |
| Applicant | IMAGE DIAGNOST INTERNATIONAL GMBH BALANSTR. 57 Muenchen, DE 81541 |
| Contact | Peter Heinlein |
| Correspondent | Stefan Preiss TUV SUD AMERICA INC. 1775 OLD HIGHWAY 8 NW New Brighton, MN 55112 -1891 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2008-06-11 |
| Decision Date | 2008-07-29 |
| Summary: | summary |