The following data is part of a premarket notification filed by General Electric Co. with the FDA for Ge Veo Reconstruction Option.
| Device ID | K103489 |
| 510k Number | K103489 |
| Device Name: | GE VEO RECONSTRUCTION OPTION |
| Classification | System, X-ray, Tomography, Computed |
| Applicant | GENERAL ELECTRIC CO. 3000 N. GRANDVIEW BLVD. W1140 Waukesha, WI 53188 |
| Contact | Andrew J Menden |
| Correspondent | Andrew J Menden GENERAL ELECTRIC CO. 3000 N. GRANDVIEW BLVD. W1140 Waukesha, WI 53188 |
| Product Code | JAK |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-11-26 |
| Decision Date | 2011-09-09 |
| Summary: | summary |