The following data is part of a premarket notification filed by Ge Medical Systems with the FDA for Lightspeed 4.0 Ct Scanner System.
| Device ID | K013561 |
| 510k Number | K013561 |
| Device Name: | LIGHTSPEED 4.0 CT SCANNER SYSTEM |
| Classification | System, X-ray, Tomography, Computed |
| Applicant | GE MEDICAL SYSTEMS 16800 RYERSON RD. New Berlin, WI 53151 |
| Contact | Larry A Kroger |
| Correspondent | Reiner Krumme 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 | 2001-10-26 |
| Decision Date | 2001-11-08 |
| Summary: | summary |