The following data is part of a premarket notification filed by Ge Healthcare with the FDA for Signapioneer.
| Device ID | K160621 |
| 510k Number | K160621 |
| Device Name: | SIGNAPioneer |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | GE HEALTHCARE 3200 N. GRANDVIEW BLVD. Waukesha, WI 53188 |
| Contact | Glen Sabin |
| Correspondent | Glen Sabin 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 | 2016-03-04 |
| Decision Date | 2016-03-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840682145770 | K160621 | 000 |
| 00195278005502 | K160621 | 000 |