The following data is part of a premarket notification filed by Ge Healthcare(tianjin) Company Limited with the FDA for Signa Voyager, Signa Voyager Quantum.
| Device ID | K192426 |
| 510k Number | K192426 |
| Device Name: | Signa Voyager, Signa Voyager Quantum |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | GE Healthcare(Tianjin) Company Limited No. 266 Jinjsan Road, Tianjin Airport Economic Area Tianjin, CN 300308 |
| Contact | Yuan Ma |
| Correspondent | Yuan Ma GE Healthcare(Tianjin) Company Limited No. 266 Jinjsan Road, Tianjin Airport Economic Area Tianjin, CN 300308 |
| Product Code | LNH |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-09-05 |
| Decision Date | 2019-10-01 |