The following data is part of a premarket notification filed by Ge Healthcare(tianjin) Company Limited with the FDA for Signa Artist Evo.
| Device ID | K213603 |
| 510k Number | K213603 |
| Device Name: | SIGNA Artist Evo |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | GE Healthcare(Tianjin) Company Limited No. 266 Jinjsan Road, Tianjin Airport Economic Area Tianjin, CN 300308 |
| Contact | Qiang Ding |
| Correspondent | Glen Sabin GE Healthcare (GE Medical Systems, LLC) 3200 N Grandview Blvd. Waukesha, WI 53188 |
| Product Code | LNH |
| Subsequent Product Code | LNI |
| Subsequent Product Code | MOS |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-11-15 |
| Decision Date | 2022-02-11 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00195278481382 | K213603 | 000 |