The following data is part of a premarket notification filed by Fischer Imaging Corp. with the FDA for Mammoscan.
| Device ID | K923061 |
| 510k Number | K923061 |
| Device Name: | MAMMOSCAN |
| Classification | System, X-ray, Mammographic |
| Applicant | FISCHER IMAGING CORP. 12300 NORTH GRANT ST. Denver, CO 80241 -3120 |
| Contact | James W Morgan |
| Correspondent | James W Morgan 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 | 1992-06-25 |
| Decision Date | 1992-09-10 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() MAMMOSCAN 79100764 not registered Dead/Abandoned |
Nauchno-proizvodstvennoe chastnoe unitarnoe predpriyatie "ADANI" 2011-07-11 |