The following data is part of a premarket notification filed by Shimadzu Corp. with the FDA for X-ray Tv System Sonial Vision G4.
| Device ID | K131075 |
| 510k Number | K131075 |
| Device Name: | X-RAY TV SYSTEM SONIAL VISION G4 |
| Classification | System, X-ray, Fluoroscopic, Image-intensified |
| Applicant | SHIMADZU CORP. 20101 SOUTH VERMONT AVE. Torrance, CA 90502 -1328 |
| Contact | Don Karle |
| Correspondent | Don Karle SHIMADZU CORP. 20101 SOUTH VERMONT AVE. Torrance, CA 90502 -1328 |
| Product Code | JAA |
| CFR Regulation Number | 892.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-04-17 |
| Decision Date | 2014-03-28 |
| Summary: | summary |