The following data is part of a premarket notification filed by Ge Medical Systems, Llc with the FDA for Optima Mr450w.
| Device ID | K091536 |
| 510k Number | K091536 |
| Device Name: | OPTIMA MR450W |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | GE MEDICAL SYSTEMS, LLC 3200 N. GRANDVIEW BLVD. Waukesha, WI 53188 |
| Contact | Mark Stauffer |
| Correspondent | Daniel W Lehtonen INTERTEK TESTING SERVICES 2307 EAST AURORA ROAD UNIT B7 Twinsburg, OH 44087 |
| Product Code | LNH |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2009-05-26 |
| Decision Date | 2009-07-17 |
| Summary: | summary |