The following data is part of a premarket notification filed by Ge Medical Systems, Llc with the FDA for Optima Xr240amx.
| Device ID | K162990 |
| 510k Number | K162990 |
| Device Name: | Optima XR240amx |
| Classification | System, X-ray, Mobile |
| Applicant | GE Medical Systems, LLC 3000 N. Grandview Blvd. Waukesha, WI 53188 |
| Contact | Chris Paulik |
| Correspondent | Chris Paulik GE Medical Systems, LLC 3000 N. Grandview Blvd. Waukesha, WI 53188 |
| Product Code | IZL |
| CFR Regulation Number | 892.1720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-10-27 |
| Decision Date | 2016-11-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840682145749 | K162990 | 000 |
| 00840682123686 | K162990 | 000 |
| 00840682122351 | K162990 | 000 |