The following data is part of a premarket notification filed by Ge Healthcare with the FDA for Signa Voyager.
| Device ID | K161567 |
| 510k Number | K161567 |
| Device Name: | SIGNA Voyager |
| 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-06-07 |
| Decision Date | 2016-09-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840682120746 | K161567 | 000 |
| 00840682120227 | K161567 | 000 |
| 00840682120210 | K161567 | 000 |
| 00840682108607 | K161567 | 000 |