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 |