The following data is part of a premarket notification filed by Ge Medical Systems with the FDA for Hispeed Ct/i With Performix Tube And Warp Scan Option.
| Device ID | K964746 |
| 510k Number | K964746 |
| Device Name: | HISPEED CT/I WITH PERFORMIX TUBE AND WARP SCAN OPTION |
| Classification | System, X-ray, Tomography, Computed |
| 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 | JAK |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-11-26 |
| Decision Date | 1997-01-24 |
| Summary: | summary |