The following data is part of a premarket notification filed by Ge Medical Systems with the FDA for Prestilix 1694 D Image Intensified Fluorosccopic.
| Device ID | K924310 |
| 510k Number | K924310 |
| Device Name: | PRESTILIX 1694 D IMAGE INTENSIFIED FLUOROSCCOPIC |
| Classification | System, Image Processing, Radiological |
| Applicant | GE MEDICAL SYSTEMS PO BOX 414 Milwaukee, WI 53201 |
| Contact | Larry A Kroger |
| Correspondent | Larry A Kroger GE MEDICAL SYSTEMS PO 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 | 1992-08-26 |
| Decision Date | 1993-01-21 |