The following data is part of a premarket notification filed by Ge Medical Systems, Llc with the FDA for Mr Radiation Oncology Options.
| Device ID | K102155 |
| 510k Number | K102155 |
| Device Name: | MR RADIATION ONCOLOGY OPTIONS |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | GE MEDICAL SYSTEMS, LLC 3200 N. GRANDVIEW BLVD. Waukesha, WI 53188 |
| Contact | Tracey Fox |
| Correspondent | Tracey Fox GE MEDICAL SYSTEMS, LLC 3200 N. GRANDVIEW BLVD. Waukesha, WI 53188 |
| Product Code | LNH |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-07-30 |
| Decision Date | 2010-08-31 |
| Summary: | summary |