The following data is part of a premarket notification filed by Fischer Imaging Corp. with the FDA for Genesis 180.
| Device ID | K883863 |
| 510k Number | K883863 |
| Device Name: | GENESIS 180 |
| Classification | Table, Radiographic, Tilting |
| Applicant | FISCHER IMAGING CORP. 12300 NORTH GRANT ST. Denver, CO 80241 -3120 |
| Contact | Richard S Lucas |
| Correspondent | Richard S Lucas FISCHER IMAGING CORP. 12300 NORTH GRANT ST. Denver, CO 80241 -3120 |
| Product Code | IXR |
| CFR Regulation Number | 892.1980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-09-13 |
| Decision Date | 1988-10-21 |