The following data is part of a premarket notification filed by Ge Medical Systems, Llc with the FDA for 1.5t Signa Hdxt 3.0t Signa Hdxt Signa Vibrant.
| Device ID | K121676 |
| 510k Number | K121676 |
| Device Name: | 1.5T SIGNA HDXT 3.0T SIGNA HDXT SIGNA VIBRANT |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | GE MEDICAL SYSTEMS, LLC 3200 N. GRANDVIEW BLVD. Waukesha, WI 53188 |
| Contact | Shashidhar Cs |
| Correspondent | Shashidhar Cs 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 | Yes |
| Date Received | 2012-06-07 |
| Decision Date | 2012-09-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840682144261 | K121676 | 000 |
| 00840682116787 | K121676 | 000 |
| 00840682115964 | K121676 | 000 |
| 00840682115889 | K121676 | 000 |
| 00840682108607 | K121676 | 000 |
| 00195278122643 | K121676 | 000 |