The following data is part of a premarket notification filed by Fischer Imaging Corp. with the FDA for Mammotest.
| Device ID | K042095 |
| 510k Number | K042095 |
| Device Name: | MAMMOTEST |
| Classification | System, X-ray, Mammographic |
| Applicant | FISCHER IMAGING CORP. 12300 NORTH GRANT ST. Denver, CO 80241 -3120 |
| Contact | Robert G Schueppert |
| Correspondent | Robert G Schueppert FISCHER IMAGING CORP. 12300 NORTH GRANT ST. Denver, CO 80241 -3120 |
| Product Code | IZH |
| CFR Regulation Number | 892.1710 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-08-03 |
| Decision Date | 2004-10-29 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() MAMMOTEST 85959215 4581477 Live/Registered |
Siemens Aktiengesellschaft 2013-06-13 |
![]() MAMMOTEST 74186715 1700417 Dead/Cancelled |
Fischer Imaging Corporation 1991-07-19 |