The following data is part of a premarket notification filed by Shimadzu Corp. with the FDA for X-ray Tv System Sonialvision G4.
| Device ID | K142341 |
| 510k Number | K142341 |
| Device Name: | X-RAY TV SYSTEM SONIALVISION G4 |
| Classification | System, X-ray, Fluoroscopic, Image-intensified |
| Applicant | SHIMADZU CORP. 1 NISHINOKYO-KUWABARACHO NAKAYGO-KU Kyoto, JP 604-8511 |
| Contact | Toshio Kadowaki |
| Correspondent | Don Karle SHIMADZU MEDICAL SYSTEMS 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 | 2014-08-21 |
| Decision Date | 2015-03-06 |
| Summary: | summary |