The following data is part of a premarket notification filed by Fischer Imaging Corp. with the FDA for Ximatron/ct Option.
| Device ID | K910647 |
| 510k Number | K910647 |
| Device Name: | XIMATRON/CT OPTION |
| Classification | System, Simulation, Radiation Therapy |
| 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 | KPQ |
| CFR Regulation Number | 892.5840 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-02-13 |
| Decision Date | 1991-09-19 |