The following data is part of a premarket notification filed by Fisher Imaging Corp. with the FDA for Image Intensified Fluoroscopic X-ray System.
| Device ID | K952456 |
| 510k Number | K952456 |
| Device Name: | IMAGE INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM |
| Classification | System, X-ray, Fluoroscopic, Image-intensified |
| Applicant | FISHER IMAGING CORP. 12300 NORTH GRANT ST. Denver, CO 80241 -3120 |
| Contact | Samuella D Emrich |
| Correspondent | Samuella D Emrich FISHER IMAGING CORP. 12300 NORTH GRANT ST. Denver, CO 80241 -3120 |
| Product Code | JAA |
| CFR Regulation Number | 892.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-05-25 |
| Decision Date | 1995-06-16 |