The following data is part of a premarket notification filed by Ge Medical Systems, Inc. with the FDA for Ge Lightspeed Rt16 / Lightspeed Xtra V2 Ct System (aka Ge Lightspeed Rt16 / Lightspeed Xtra Ct System.
| Device ID | K082104 |
| 510k Number | K082104 |
| Device Name: | GE LIGHTSPEED RT16 / LIGHTSPEED XTRA V2 CT SYSTEM (AKA GE LIGHTSPEED RT16 / LIGHTSPEED XTRA CT SYSTEM |
| Classification | System, X-ray, Tomography, Computed |
| Applicant | GE MEDICAL SYSTEMS, INC. 3000 N. GRANDVIEW BLVD. W-706 Waukesha, WI 53188 |
| Contact | Steven Kachelmeyer |
| Correspondent | Jay Y Kogoma INTERTEK TESTING SERVICES 2307 EAST AURORA ROAD UNIT B7 Twinsburg, OH 44087 |
| Product Code | JAK |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2008-07-25 |
| Decision Date | 2008-09-02 |
| Summary: | summary |