The following data is part of a premarket notification filed by Ge Healthcare Japan Corporation with the FDA for Discovery Mr750w 3.0t.
| Device ID | K103327 |
| 510k Number | K103327 |
| Device Name: | DISCOVERY MR750W 3.0T |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | GE HEALTHCARE JAPAN CORPORATION 7-127, ASAHIGAOKA 4-CHROME Hino-shi, Tokyo, JP 191-8503 |
| Contact | Toru Shimizu |
| Correspondent | Toru Shimizu GE HEALTHCARE JAPAN CORPORATION 7-127, ASAHIGAOKA 4-CHROME Hino-shi, Tokyo, JP 191-8503 |
| 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 | 2010-11-12 |
| Decision Date | 2011-09-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840682109741 | K103327 | 000 |
| 00840682108577 | K103327 | 000 |
| 00840682105095 | K103327 | 000 |
| 00840682102483 | K103327 | 000 |