The following data is part of a premarket notification filed by Ge Healthcare with the FDA for Omni Legend.
| Device ID | K221932 |
| 510k Number | K221932 |
| Device Name: | Omni Legend |
| Classification | System, Tomography, Computed, Emission |
| 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 | KPS |
| CFR Regulation Number | 892.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-07-01 |
| Decision Date | 2022-09-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00195278592309 | K221932 | 000 |
| 00195278792822 | K221932 | 000 |
| 00195278454218 | K221932 | 000 |
| 00195278901439 | K221932 | 000 |