The following data is part of a premarket notification filed by Ge Medical Systems, Llc with the FDA for Mr-touch Option.
| Device ID | K083421 |
| 510k Number | K083421 |
| Device Name: | MR-TOUCH OPTION |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | GE MEDICAL SYSTEMS, LLC 3200 N. GRANDVIEW BLVD. Waukesha, WI 53188 |
| Contact | Daniel Biank |
| Correspondent | Daniel Biank 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 | 2008-11-19 |
| Decision Date | 2009-07-24 |
| Summary: | summary |