The following data is part of a premarket notification filed by Ge Medical Systems with the FDA for Ct Prospeed Family.
| Device ID | K944013 |
| 510k Number | K944013 |
| Device Name: | CT PROSPEED FAMILY |
| Classification | System, X-ray, Tomography, Computed |
| Applicant | GE MEDICAL SYSTEMS 3000 N. GRANDVIEW BLVD. Waukesha, WI 53188 |
| Contact | Larry A Kroger |
| Correspondent | Larry A Kroger GE MEDICAL SYSTEMS 3000 N. GRANDVIEW BLVD. Waukesha, WI 53188 |
| Product Code | JAK |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-08-16 |
| Decision Date | 1995-02-07 |