The following data is part of a premarket notification filed by Ge Healthcare with the FDA for Senolris.
| Device ID | K160937 |
| 510k Number | K160937 |
| Device Name: | Senolris |
| Classification | System, Image Processing, Radiological |
| Applicant | GE Healthcare Oskar-Schlemmer-Str. 11 Munich, DE D-80807 |
| Contact | Mounir Zaouali |
| Correspondent | Mounir Zaouali GE Healthcare Oskar-Schlemmer-Str. 11 Munich, DE D-80807 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-04-04 |
| Decision Date | 2016-08-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840682140614 | K160937 | 000 |
| 00840682104395 | K160937 | 000 |
| 00840682147767 | K160937 | 000 |