The following data is part of a premarket notification filed by Ge Healthcare with the FDA for Signa Pioneer.
| Device ID | K153003 |
| 510k Number | K153003 |
| Device Name: | SIGNA Pioneer |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | GE HEALTHCARE 3200 N. Grandview Blvd. Waukesha, WI 53188 |
| Contact | Andrew Menden |
| Correspondent | Andrew Menden GE HEALTHCARE 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 | 2015-10-13 |
| Decision Date | 2015-10-27 |
| Summary: | summary |