The following data is part of a premarket notification filed by Fischer Imaging Corp. with the FDA for Fischer Pps/mammotest Mammography System.
| Device ID | K861692 |
| 510k Number | K861692 |
| Device Name: | FISCHER PPS/MAMMOTEST MAMMOGRAPHY SYSTEM |
| Classification | System, X-ray, Mammographic |
| Applicant | FISCHER IMAGING CORP. 1800 ELMHURST RD. Elk Grove Village, IL 60007 |
| Contact | Norval Northcott |
| Correspondent | Norval Northcott FISCHER IMAGING CORP. 1800 ELMHURST RD. Elk Grove Village, IL 60007 |
| Product Code | IZH |
| CFR Regulation Number | 892.1710 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-05-02 |
| Decision Date | 1986-12-15 |