The following data is part of a premarket notification filed by Fischer Imaging Corp. with the FDA for Rsx-525hf.
| Device ID | K943504 |
| 510k Number | K943504 |
| Device Name: | RSX-525HF |
| Classification | Generator, High-voltage, X-ray, Diagnostic |
| Applicant | FISCHER IMAGING CORP. 2301 WINDSOR CT. Addison, IL 60101 |
| Contact | William J Engel |
| Correspondent | William J Engel FISCHER IMAGING CORP. 2301 WINDSOR CT. Addison, IL 60101 |
| Product Code | IZO |
| CFR Regulation Number | 892.1700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-07-20 |
| Decision Date | 1994-08-17 |