The following data is part of a premarket notification filed by Ge Medical Systems, Llc with the FDA for Discovery Mr750 3.0t; Discovery Mr750w 3.0t;discovery Mr450 1.5t; Discovery Mr450w 1.5t; Signa Architect And Signa Artist.
| Device ID | K163331 |
| 510k Number | K163331 |
| Device Name: | Discovery MR750 3.0T; Discovery MR750w 3.0T;Discovery MR450 1.5T; Discovery MR450w 1.5T; SIGNA Architect And SIGNA Artist |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | GE Medical Systems, LLC 3200 Grandview Blvd Waukesha, WI 53188 |
| Contact | Mary A. Mayka |
| Correspondent | Mary A. Mayka GE Medical Systems, LLC 3200 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 | 2016-11-28 |
| Decision Date | 2017-03-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840682146104 | K163331 | 000 |
| 00840682147095 | K163331 | 000 |
| 00195278023643 | K163331 | 000 |
| 00195278210036 | K163331 | 000 |
| 00195278126443 | K163331 | 000 |
| 00195278117021 | K163331 | 000 |