The following data is part of a premarket notification filed by Nemoto Kyorindo Co., Ltd. with the FDA for Sonic Shot Gx.
| Device ID | K091734 |
| 510k Number | K091734 |
| Device Name: | SONIC SHOT GX |
| Classification | Injector, Contrast Medium, Automatic |
| Applicant | NEMOTO KYORINDO CO., LTD. 2-12-4 AOKI Kawaguchi-shi, Saitama, JP 332-0031 |
| Contact | Masahiro Sakakibara |
| Correspondent | Masahiro Sakakibara NEMOTO KYORINDO CO., LTD. 2-12-4 AOKI Kawaguchi-shi, Saitama, JP 332-0031 |
| Product Code | IZQ |
| CFR Regulation Number | 870.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-06-11 |
| Decision Date | 2010-05-21 |
| Summary: | summary |