The following data is part of a premarket notification filed by Ge Medical Systems, Inc. with the FDA for Hispeed Dual.
| Device ID | K021491 |
| 510k Number | K021491 |
| Device Name: | HISPEED DUAL |
| Classification | System, X-ray, Tomography, Computed |
| Applicant | GE MEDICAL SYSTEMS, INC. 3000 N. GRANDVIEW BLVD. Waukesha, WI 53188 |
| Contact | Larry A Kroger |
| Product Code | JAK |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2002-05-09 |
| Decision Date | 2002-05-22 |
| Summary: | summary |