The following data is part of a premarket notification filed by Ge Medical Systems Scs with the FDA for Hepatic Vcar.
| Device ID | K133649 |
| 510k Number | K133649 |
| Device Name: | HEPATIC VCAR |
| Classification | System, X-ray, Tomography, Computed |
| Applicant | GE MEDICAL SYSTEMS SCS 3000 N. GRANDVIEW Waukesha, WI 53188 |
| Contact | Huy Doan |
| Correspondent | Huy Doan GE MEDICAL SYSTEMS SCS 3000 N. GRANDVIEW 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 | 2013-11-27 |
| Decision Date | 2014-04-22 |
| Summary: | summary |