The following data is part of a premarket notification filed by Volcano Corporation with the FDA for Syncvision System.
| Device ID | K151904 |
| 510k Number | K151904 |
| Device Name: | SyncVision System |
| Classification | Interventional Fluoroscopic X-ray System |
| Applicant | VOLCANO CORPORATION 1 FORTUNE DR. Billerica, MA 01821 |
| Contact | Elaine Alan |
| Correspondent | Elaine Alan VOLCANO CORPORATION 1 FORTUNE DR. Billerica, MA 01821 |
| Product Code | OWB |
| CFR Regulation Number | 892.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-07-13 |
| Decision Date | 2015-07-31 |
| Summary: | summary |