The following data is part of a premarket notification filed by Ge Medical Systems F.i. Haifa with the FDA for Xeleris 3 Processing And Review Workstation.
| Device ID | K093982 |
| 510k Number | K093982 |
| Device Name: | XELERIS 3 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 | Casey Conry UNDERWRITERS LABORATORIES, INC. 1285 WALT WHITMAN RD. Melville, NY 11747 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2009-12-24 |
| Decision Date | 2010-01-08 |
| Summary: | summary |