The following data is part of a premarket notification filed by Ge Medical Systems, Llc with the FDA for 1.5t Optima Mr430s.
| Device ID | K103238 |
| 510k Number | K103238 |
| Device Name: | 1.5T OPTIMA MR430S |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | GE MEDICAL SYSTEMS, LLC 301 BALLARDVALE STREET SUITE 4 Wilmington, MA 01887 |
| Contact | Norma Lemay |
| Correspondent | Norma Lemay GE MEDICAL SYSTEMS, LLC 301 BALLARDVALE STREET SUITE 4 Wilmington, MA 01887 |
| Product Code | LNH |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-11-02 |
| Decision Date | 2011-02-11 |
| Summary: | summary |