The following data is part of a premarket notification filed by General Electric Co. with the FDA for Image Intensified Fluoroscopic X-ray System.
| Device ID | K903196 |
| 510k Number | K903196 |
| Device Name: | IMAGE INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM |
| Classification | System, Image Processing, Radiological |
| Applicant | GENERAL ELECTRIC CO. P.O. BOX 414 Milwaukee, WI 53201 |
| Contact | Larry A Kroger |
| Correspondent | Larry A Kroger GENERAL ELECTRIC CO. P.O. BOX 414 Milwaukee, WI 53201 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-07-19 |
| Decision Date | 1990-08-10 |