The following data is part of a premarket notification filed by Shimadzu Corporation with the FDA for Sonialvision G4.
| Device ID | K190373 |
| 510k Number | K190373 |
| Device Name: | SonialVision G4 |
| Classification | System, X-ray, Fluoroscopic, Image-intensified |
| Applicant | SHIMADZU Corporation 1 Nishinokyo-Kuwabaracho Nakagyo-ku Kyoto, JP 604-8511 |
| Contact | Toshio Kadowaki |
| Correspondent | Daniel Kamm Kamm & Associates 8870 Ravello Ct Naples, FL 34114 |
| Product Code | JAA |
| CFR Regulation Number | 892.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-02-19 |
| Decision Date | 2019-03-15 |