The following data is part of a premarket notification filed by Ge Healthcare (ge Medical Systems, Llc) with the FDA for Discovery Mr750 3.0t, Discovery Mr450 1.5t, Discovery Mr750w 3.0t, Optima Mr450w 1.5t.
| Device ID | K132376 |
| 510k Number | K132376 |
| Device Name: | DISCOVERY MR750 3.0T, DISCOVERY MR450 1.5T, DISCOVERY MR750W 3.0T, OPTIMA MR450W 1.5T |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | GE HEALTHCARE (GE MEDICAL SYSTEMS, LLC) 3200 N. GRANDVIEW BLVD Waukesha, WI 53188 |
| Contact | Michelle Huettner |
| Correspondent | Michelle Huettner GE HEALTHCARE (GE MEDICAL SYSTEMS, LLC) 3200 N. GRANDVIEW BLVD Waukesha, WI 53188 |
| Product Code | LNH |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-07-30 |
| Decision Date | 2013-11-15 |
| Summary: | summary |