The following data is part of a premarket notification filed by Ge Healthcare (tianjin) Company Limited with the FDA for Signa Prime.
| Device ID | K211980 |
| 510k Number | K211980 |
| Device Name: | SIGNA Prime |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | GE Healthcare (Tianjin) Company Limited No. 266 Jingsan Road, Tianjin Airport Economic Area Tianjin, CN 300308 |
| Contact | Huande Li |
| 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 | 2021-06-25 |
| Decision Date | 2022-01-16 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840682146302 | K211980 | 000 |