The following data is part of a premarket notification filed by Fischer Imaging Corp. with the FDA for Mammopath.
| Device ID | K021113 |
| 510k Number | K021113 |
| Device Name: | MAMMOPATH |
| Classification | Cabinet, X-ray System |
| Applicant | FISCHER IMAGING CORP. 12300 NORTH GRANT ST. Denver, CO 80241 -3120 |
| Contact | Samir B Paliwal |
| Correspondent | Samir B Paliwal FISCHER IMAGING CORP. 12300 NORTH GRANT ST. Denver, CO 80241 -3120 |
| Product Code | MWP |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-04-05 |
| Decision Date | 2002-06-13 |