The following data is part of a premarket notification filed by Ge Medical Systems, Llc with the FDA for Discovery Mr750w 3.0t.
| Device ID | K130115 |
| 510k Number | K130115 |
| Device Name: | DISCOVERY MR750W 3.0T |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | GE MEDICAL SYSTEMS, LLC 3200 N. GRANDVIEW BLVD. Waukesha, WI 53188 |
| Contact | Michelle Huettner |
| Correspondent | Michelle Huettner GE MEDICAL SYSTEMS, LLC 3200 N. GRANDVIEW BLVD. Waukesha, WI 53188 |
| Product Code | LNH |
| Subsequent Product Code | LNI |
| Subsequent Product Code | MOS |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-01-16 |
| Decision Date | 2013-05-23 |
| Summary: | summary |