The following data is part of a premarket notification filed by General Electric Co. with the FDA for Hispeed Lx//i, Hispeed Fx/i, And Hispeed Dx/i Family Of Systems.
| Device ID | K980169 |
| 510k Number | K980169 |
| Device Name: | HISPEED LX//I, HISPEED FX/I, AND HISPEED DX/I FAMILY OF SYSTEMS |
| Classification | System, X-ray, Tomography, Computed |
| 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 | JAK |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-01-16 |
| Decision Date | 1998-04-13 |
| Summary: | summary |