The following data is part of a premarket notification filed by Ge Medical Systems with the FDA for Xeleris 2 Processing And Review Workstation.
| Device ID | K051673 |
| 510k Number | K051673 |
| Device Name: | XELERIS 2 PROCESSING AND REVIEW WORKSTATION |
| Classification | System, Image Processing, Radiological |
| Applicant | GE MEDICAL SYSTEMS 3000 N GRANDVIEW BLVD. W-709 Waukesha, WI 53188 |
| Contact | Larry A Kroger |
| Correspondent | Larry A Kroger GE MEDICAL SYSTEMS 3000 N GRANDVIEW BLVD. W-709 Waukesha, WI 53188 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-06-23 |
| Decision Date | 2005-07-18 |
| Summary: | summary |