The following data is part of a premarket notification filed by Ge Healthcare (ge Medical Systems,llc) with the FDA for Signa Creator, Signa Explorer.
| Device ID | K143251 |
| 510k Number | K143251 |
| Device Name: | SIGNA Creator, SIGNA Explorer |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | GE HEALTHCARE (GE MEDICAL SYSTEMS,LLC) 3200 N. GRANDVIEW BLVD. Waukesha, WI 53188 |
| Contact | Glen Sabin |
| Correspondent | Glen Sabin GE HEALTHCARE (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 | 2014-11-12 |
| Decision Date | 2015-02-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840682146814 | K143251 | 000 |
| 00840682118033 | K143251 | 000 |
| 00840682116794 | K143251 | 000 |
| 00840682113786 | K143251 | 000 |
| 00840682113762 | K143251 | 000 |