The following data is part of a premarket notification filed by Ge Medical Systems with the FDA for Ct Sytec 6000 Computed Tomography System.
| Device ID | K921192 |
| 510k Number | K921192 |
| Device Name: | CT SYTEC 6000 COMPUTED TOMOGRAPHY SYSTEM |
| Classification | System, X-ray, Tomography, Computed |
| Applicant | GE MEDICAL SYSTEMS PO BOX 414 Milwaukee, WI 53201 |
| Contact | Larry Kroger |
| Correspondent | Larry Kroger GE MEDICAL SYSTEMS PO 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 | 1992-03-12 |
| Decision Date | 1992-10-20 |