The following data is part of a premarket notification filed by Ge Medical Systems, Llc with the FDA for Brivoxr285amx, Optima Xr200amx, Optimaxr220amx.
| Device ID | K103476 |
| 510k Number | K103476 |
| Device Name: | BRIVOXR285AMX, OPTIMA XR200AMX, OPTIMAXR220AMX |
| Classification | System, X-ray, Mobile |
| 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 | IZL |
| CFR Regulation Number | 892.1720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-11-24 |
| Decision Date | 2011-06-16 |
| Summary: | summary |