The following data is part of a premarket notification filed by Ge Medical Systems with the FDA for Modification To: Lightspeed Plus Mobile Ct System.
| Device ID | K012836 |
| 510k Number | K012836 |
| Device Name: | MODIFICATION TO: LIGHTSPEED PLUS MOBILE CT SYSTEM |
| Classification | System, X-ray, Tomography, Computed |
| Applicant | GE MEDICAL SYSTEMS P.O. BOX 414 Milwaukee, WI 53188 |
| Contact | Larry A Kroger |
| Correspondent | Larry A Kroger GE MEDICAL SYSTEMS P.O. BOX 414 Milwaukee, WI 53188 |
| Product Code | JAK |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-08-23 |
| Decision Date | 2001-09-07 |
| Summary: | summary |