The following data is part of a premarket notification filed by Fischer Imaging Corp. with the FDA for Athena Hfx.
| Device ID | K945619 |
| 510k Number | K945619 |
| Device Name: | ATHENA HFX |
| Classification | System, X-ray, Mammographic |
| Applicant | FISCHER IMAGING CORP. 12300 NORTH GRANT ST. Denver, CO 80241 -3120 |
| Contact | Samuella D Emrich |
| Correspondent | Samuella D Emrich 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 | 1994-11-15 |
| Decision Date | 1995-03-23 |