The following data is part of a premarket notification filed by Ge Medical Systems with the FDA for Lightspeed 5.0 Computed Tomography System.
| Device ID | K030420 |
| 510k Number | K030420 |
| Device Name: | LIGHTSPEED 5.0 COMPUTED TOMOGRAPHY SYSTEM |
| Classification | System, X-ray, Tomography, Computed |
| Applicant | GE MEDICAL SYSTEMS 3000 NORTH GRANDVIEW BLVD. Waukesha, WI 53188 |
| Contact | John W Jaeckle |
| Correspondent | John W Jaeckle GE MEDICAL SYSTEMS 3000 NORTH GRANDVIEW BLVD. Waukesha, 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 | 2003-02-10 |
| Decision Date | 2003-03-10 |
| Summary: | summary |