The following data is part of a premarket notification filed by Ge Healthcare with the FDA for Ge Lightspeed Ct750 Hd (lightspeed 8.0).
| Device ID | K081105 |
| 510k Number | K081105 |
| Device Name: | GE LIGHTSPEED CT750 HD (LIGHTSPEED 8.0) |
| Classification | System, X-ray, Tomography, Computed |
| Applicant | GE HEALTHCARE 3000 N. GRANDVIEW BLVD. Waukesha, WI 53188 |
| Contact | Andrew Menden |
| 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 | 2008-04-18 |
| Decision Date | 2008-05-09 |
| Summary: | summary |