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 |