The following data is part of a premarket notification filed by Ge Healthcare with the FDA for Xeleris 4.0 Processing And Review Workstation.
| Device ID | K153355 |
| 510k Number | K153355 |
| Device Name: | Xeleris 4.0 Processing And Review Workstation |
| Classification | System, Image Processing, Radiological |
| Applicant | GE HEALTHCARE 4 HAYOZMA STREET Tirat Hacarmel, IL 30200 |
| Contact | Efrat Hartog-david |
| Correspondent | Efrat Hartog-david GE HEALTHCARE 4 HAYOZMA STREET Tirat Hacarmel, IL 30200 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-11-20 |
| Decision Date | 2016-03-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840682147545 | K153355 | 000 |
| 00840682152082 | K153355 | 000 |
| 00840682134897 | K153355 | 000 |
| 00840682109819 | K153355 | 000 |