The following data is part of a premarket notification filed by Ge Medical Systems F.i. Haifa with the FDA for Xeleris 3.1 Processing And Review Workstation.
| Device ID | K130884 |
| 510k Number | K130884 |
| Device Name: | XELERIS 3.1 PROCESSING AND REVIEW WORKSTATION |
| Classification | System, Image Processing, Radiological |
| Applicant | GE MEDICAL SYSTEMS F.I. HAIFA 4 HAYOZMA ST. Tirat Hacarmel, IL 30200 |
| Contact | Eli Werner |
| Correspondent | Ned Devine UNDERWRITERS LABORATORIES, INC. 333 PFINGSTEN RD. Northbrook, IL 60062 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2013-03-29 |
| Decision Date | 2013-04-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840682119306 | K130884 | 000 |