The following data is part of a premarket notification filed by Volcano Corporation with the FDA for Syncvision System.
| Device ID | K190626 |
| 510k Number | K190626 |
| Device Name: | SyncVision System |
| Classification | Interventional Fluoroscopic X-ray System |
| Applicant | Volcano Corporation 3721 Valley Centre Dr., Suite 500 San Diego, CA 92130 |
| Contact | Rand Daoud |
| Correspondent | Rand Daoud Volcano Corporation 3721 Valley Centre Dr., Suite 500 San Diego, CA 92130 |
| Product Code | OWB |
| CFR Regulation Number | 892.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-03-11 |
| Decision Date | 2019-04-12 |