The following data is part of a premarket notification filed by Ge Medical Systems, Llc with the FDA for Signa 7.0t.
| Device ID | K201615 |
| 510k Number | K201615 |
| Device Name: | SIGNA 7.0T |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | GE Medical Systems, LLC 3200 Grandview Blvd Waukesha, WI 53188 |
| Contact | Brian R. Zielski |
| Correspondent | Brian R. Zielski GE Medical Systems, LLC 3200 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 | 2020-06-15 |
| Decision Date | 2020-10-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00814848020515 | K201615 | 000 |
| 00195278483713 | K201615 | 000 |