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 |