The following data is part of a premarket notification filed by Ge Medical Systems Scs with the FDA for Gsi Viewer With Vue Option.
| Device ID | K121827 |
| 510k Number | K121827 |
| Device Name: | GSI VIEWER WITH VUE OPTION |
| Classification | System, X-ray, Tomography, Computed |
| Applicant | GE MEDICAL SYSTEMS SCS 3000 NORTH GRANDVIEW W1140 Waukesha, WI 53188 |
| Contact | Helen Peng |
| Correspondent | Helen Peng GE MEDICAL SYSTEMS SCS 3000 NORTH GRANDVIEW 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 | 2012-06-21 |
| Decision Date | 2012-09-13 |
| Summary: | summary |