The following data is part of a premarket notification filed by Fischer Imaging Corp. with the FDA for Fischer Imaging Fx325r X-ray Generator.
| Device ID | K860736 |
| 510k Number | K860736 |
| Device Name: | FISCHER IMAGING FX325R X-RAY GENERATOR |
| Classification | Generator, High-voltage, X-ray, Diagnostic |
| Applicant | FISCHER IMAGING CORP. 12300 NORTH GRANT ST. Denver, CO 80241 -3120 |
| Contact | Robert K Patton |
| Correspondent | Robert K Patton FISCHER IMAGING CORP. 12300 NORTH GRANT ST. Denver, CO 80241 -3120 |
| Product Code | IZO |
| CFR Regulation Number | 892.1700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-02-27 |
| Decision Date | 1986-04-17 |