The following data is part of a premarket notification filed by Ge Healthcare with the FDA for Xeleris V Processing And Review Systems.
| Device ID | K201103 |
| 510k Number | K201103 |
| Device Name: | Xeleris V Processing And Review Systems |
| Classification | System, Image Processing, Radiological |
| Applicant | GE Healthcare 4 Hayozma Street Tirat Hacarmel, IL 30200 |
| Contact | Alexandra Lifshits |
| Correspondent | Alexandra Lifshits 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 | 2020-04-24 |
| Decision Date | 2020-09-25 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00195278245021 | K201103 | 000 |