The following data is part of a premarket notification filed by Fischer Imaging Corp. with the FDA for Sis 2000 Mammographic X-ray System.
| Device ID | K885127 |
| 510k Number | K885127 |
| Device Name: | SIS 2000 MAMMOGRAPHIC X-RAY SYSTEM |
| Classification | Camera, Multi Format, Radiological |
| Applicant | FISCHER IMAGING CORP. 12300 NORTH GRANT ST. Denver, CO 80241 -3120 |
| Contact | Richard Lucas |
| Correspondent | Richard Lucas FISCHER IMAGING CORP. 12300 NORTH GRANT ST. Denver, CO 80241 -3120 |
| Product Code | LMC |
| CFR Regulation Number | 892.2040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-12-12 |
| Decision Date | 1989-02-16 |