The following data is part of a premarket notification filed by Ge Medical Systems, Llc with the FDA for Ge Lightspeed Xtra Ct Scanner System.
| Device ID | K060052 |
| 510k Number | K060052 |
| Device Name: | GE LIGHTSPEED XTRA CT SCANNER SYSTEM |
| Classification | System, X-ray, Tomography, Computed |
| Applicant | GE MEDICAL SYSTEMS, LLC 3000 N. GRANDVIEW BLVD. Waukesha, WI 53188 |
| Contact | Glen E Sabin |
| Correspondent | Tamas Borsai 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 | 2006-01-06 |
| Decision Date | 2006-04-19 |
| Summary: | summary |