The following data is part of a premarket notification filed by Ge Medical Systems, Llc with the FDA for Optima Xr120.
| Device ID | K111304 |
| 510k Number | K111304 |
| Device Name: | OPTIMA XR120 |
| Classification | Device, Spot-film |
| Applicant | GE MEDICAL SYSTEMS, LLC 3000 N GRANDVIEW BLVD. Waukesha, WI 53188 |
| Contact | Nidhi Chaudhary |
| Correspondent | Nidhi Chaudhary GE MEDICAL SYSTEMS, LLC 3000 N GRANDVIEW BLVD. Waukesha, WI 53188 |
| Product Code | IXL |
| CFR Regulation Number | 892.1670 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-05-09 |
| Decision Date | 2011-07-19 |
| Summary: | summary |