The following data is part of a premarket notification filed by Ge Medical Systems, Inc. with the FDA for Lightspeed 2.0ct Scanner System.
| Device ID | K000300 |
| 510k Number | K000300 |
| Device Name: | LIGHTSPEED 2.0CT SCANNER SYSTEM |
| Classification | System, X-ray, Tomography, Computed |
| Applicant | GE MEDICAL SYSTEMS, INC. P.O. BOX 414 Milwaukee, WI 53201 |
| Contact | Larry A Kroger |
| Correspondent | Ludgev Moeller TUV RHEINLAND OF NORTH AMERICA, INC. 12 COMMERCE RD. Newton, CT 06470 |
| Product Code | JAK |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2000-01-31 |
| Decision Date | 2000-02-15 |