The following data is part of a premarket notification filed by Ge Healthcare Japan Corporation with the FDA for Signa Pioneer.
| Device ID | K143345 |
| 510k Number | K143345 |
| Device Name: | SIGNA Pioneer |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | GE HEALTHCARE JAPAN CORPORATION 7-127, Asahigaoka 4-chome Hino-shi, JP 191-8503 |
| Contact | Toru Shimizu |
| Correspondent | Toru Shimizu GE HEALTHCARE JAPAN CORPORATION 7-127, Asahigaoka 4-chome Hino-shi, JP 191-8503 |
| Product Code | LNH |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-11-21 |
| Decision Date | 2015-07-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840682115858 | K143345 | 000 |
| 00840682108881 | K143345 | 000 |
| 00840682108867 | K143345 | 000 |
| 00840682106504 | K143345 | 000 |
| 00840682104401 | K143345 | 000 |