The following data is part of a premarket notification filed by Ge Medical Systems, Llc with the FDA for Lightspeed 7.0 Ct Scanner System.
| Device ID | K040372 |
| 510k Number | K040372 |
| Device Name: | LIGHTSPEED 7.0 CT SCANNER SYSTEM |
| Classification | System, X-ray, Tomography, Computed |
| Applicant | GE MEDICAL SYSTEMS, LLC 3000 N. GRANDVIEW BLVD. Waukesha, WI 53188 |
| Contact | John W Jaeckle |
| Correspondent | Juergen Welte TUV RHEINLAND OF NORTH AMERICA, INC. 1279 QUARRY LANE, SUITE A Pleasanton, CA 94566 |
| Product Code | JAK |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2004-02-17 |
| Decision Date | 2004-03-01 |
| Summary: | summary |